510kDecisions.com

FDA 510(k) Applications for Medical Device Product Code "DQK"
(Computer, Diagnostic, Programmable)

FDA 510(k) Number Applicant Device Name Decision Date
K932954 A-VOX SYSTEMS, INC. AVOXIMETER 12/27/1993
K905248 ADVANCED TECHNOLOGY LABORATORIES, INC. NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS 02/28/1991
K930806 AGILENT TECHNOLOGIES ZYMED HOLTER SCANNER MODEL 2010 04/25/1994
K931900 ARCHIVAL TECHNOLOGIES, INC. COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT. 03/11/1994
K925285 B. BRAUN OF AMERICA, INC. DUALTHERM(R) CARDIAC OUTPUT COMPUTER 07/21/1993
K780530 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC AUTOMATED PHYSIOLOGIC PROFILER 04/28/1978
K090017 BIOSENSE WEBSTER, INC. CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES 10/13/2009
K103746 BIOSENSE WEBSTER, INC. CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) 01/21/2011
K112007 BIOSENSE WEBSTER, INC. CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 10/05/2011
K133916 BIOSENSE WEBSTER, INC. CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 07/01/2014
K072202 BIOSENSE WEBSTER, INC. CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) 11/19/2007
K093455 BIOSENSE WEBSTER, INC. CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES 12/04/2009
K000248 BIOSENSE WEBSTER, INC. CARTO EP NAVIGATION SYSTEM 05/05/2000
K992968 BIOSENSE WEBSTER, INC. CARTO EP NAVIGATION SYSTEM 09/29/1999
K042681 BIOSENSE WEBSTER, INC. CARTO RMT EP NAVIGATION SYSTEM 09/29/2005
K091789 BIOSENSE WEBSTER, INC. CARTO RMT EP NAVIGATION SYSTEM V8 10/01/2009
K020863 BIOSENSE WEBSTER, INC. CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM 01/09/2003
K013083 BIOSENSE WEBSTER, INC. CARTO XP EP NAVIGATION SYSTEM 11/21/2001
K042999 BIOSENSE WEBSTER, INC. CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 03/21/2005
K093566 BIOSENSE WEBSTER, INC. CARTO XP EP NAVIGATION SYSTEM, VERSION 10 06/18/2010
K070240 BIOSENSE WEBSTER, INC. CARTO XP EP NAVIGATION SYSTEM, VERSION 9 05/04/2007
K120550 BIOSENSE WEBSTER, INC. CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) 05/07/2012
K132782 BIOSENSE WEBSTER, INC. CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 01/24/2014
K000190 BIOSENSE WEBSTER, INC. MODIFICATION TO CARTO EP NAVIGATION SYSTEM 05/05/2000
K993729 BIOSENSE WEBSTER, INC. MODIFICATION TO CARTO EP NAVIGATION SYSTEM 12/03/1999
K000332 BIOSENSE WEBSTER, INC. NOGA CARDIAC NAVIGATION SYSTEM 05/04/2000
K053194 BIOSENSE WEBSTER, INC. NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE 03/09/2006
K990494 BIOSENSE, INC. MODIFICATION OF NOGA 09/03/1999
K954395 BIOSENSE, LTD. CARTO SYSTEM 12/21/1995
K950723 BIOSENSOR CORP. AMBULATORY (HOLTER) RECORDING SYSTEM 02/09/1996
K950944 BIOSENSOR CORP. AMBULATORY (HOLTER) RECORDING SYSTEM 06/18/1996
K974192 BIOSENSOR CORP. BIOSENSOR HOLTER MONITOR SYSTEM 03/04/1998
K974546 BIOSENSOR CORP. BIOSENSOR HOLTER MONITOR SYSTEM 03/04/1998
K990956 BIOSENSOR CORP. BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 06/14/1999
K003362 BOSTON SCIENTIFIC CORP. ASTRONOMER+WITH SLD 03/01/2001
K141185 BOSTON SCIENTIFIC CORP. V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM 06/06/2014
K942565 BURDICK CORP. ALTAIR-DISC RECORDER 12/05/1994
K945985 BURDICK, INC. PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 07/03/1995
K101331 C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE 10/08/2010
K113811 C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM 03/16/2012
K031000 C.R. BARD, INC. LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0 06/03/2003
K012206 CAMBRIDGE HEART, INC. ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM 10/12/2001
K003492 CAMBRIDGE HEART, INC. ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS 01/18/2001
K011324 CAMBRIDGE HEART, INC. CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM 05/23/2001
K100362 CAMBRIDGE HEART, INC. CAMBRIDGE HEART OEM 04/14/2010
K983102 CAMBRIDGE HEART, INC. CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 04/12/1999
K010756 CAMBRIDGE HEART, INC. CH 2000 CARDIAC DIAGNOSTIC SYSTEM 04/12/2001
K050225 CAMBRIDGE HEART, INC. HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM 04/07/2005
K013032 CAMTRONICS, LTD. PHYSIOLOG, SERIES 95000 06/04/2002
K131045 CARDIAC DESIGNS, LLC ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE 05/29/2013
K042849 CARDIOBIOMEDICAL CORPORATION CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) 01/13/2005
K140497 CARDIOINSIGHT TECHNOLOGIES, INC ECVUE MAPPING SYSTEM 11/19/2014
K134044 CARDIOTEK, B.V. EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM 03/31/2014
K990058 CATHDATA, INC. QMS MAPPING SYSTEM,MODEL 2000 12/15/1999
K012089 CATHEFFECTS, LLC. CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM 01/28/2002
K023370 CHEETAH MEDICAL INC. CHEETAH I.V.D.S., MODEL 2002P 12/24/2002
K840875 CLINICAL MICROSYSTEMS INTL. MULTIVARIATE DIGITAL CARDIOGRAPH 07/06/1984
K022596 CLOVER HI-TECH INC. BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) 01/31/2003
K883152 COHERENT SYSTEMS, INC. EP-STAT 10/13/1988
K871436 CORAZONIX CORP. PREDICTOR 06/19/1987
K865035 CRITICAL CARE SYSTEMS, INC. RECORD KEEPING/DATA MANAGEMENT SYSTEM 05/11/1987
K860854 CYGNUS OF SOUTH FLORIDA, INC. CRITICALC 12/08/1986
K970570 D. E. HOKANSON, INC. NIVP3 (WINDOWS VERSION OF NIVP 10/03/1997
K072752 DATADANCER MEDICAL SYSTEMS BP LIMBO XL, BPTANGO XL, BP SALSA XL 10/31/2008
K961063 DATEX MEDICAL INSTRUMENTATION, INC. AS/3 CARDIAC OUTPUT & SVO2 MODULE 05/31/1996
K052883 DATRIX CARDIOSERVER 11/01/2005
K993620 DEL MAR MEDICAL SYSTEMS, LLC. IMPRESARIO 11/12/1999
K912728 DIAGNOSTIC MEDICAL INSTRUMENTS ALTAIR 02/27/1992
K911615 DIAGNOSTIC MONITORING SOFTWARE HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 01/08/1992
K800766 DIGISONICS, INC. ECHO-COMP 04/24/1980
K042002 ELA MEDICAL INC SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER 10/20/2004
K990727 ELA MEDICAL, INC. SYNEFLASH & SYNEVIEW 11/26/1999
K002817 ELA MEDICAL, INC. SYNETEC 05/02/2001
K935186 ELECTROPHYSIOLOGY SYSTEMS, INC. ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY 01/03/1995
K082421 EMAGEON INC. HEARTSUITE HEMODYNAMICS 7.10 12/17/2008
K992479 ENDOCARDIAL SOLUTIONS, INC. ENSITE 3000 SYSTEM 12/02/1999
K001437 ENDOCARDIAL SOLUTIONS, INC. ENSITE 3000 SYSTEM, MODEL EE3000 06/07/2000
K033211 ENDOCARDIAL SOLUTIONS, INC. ENSITE SYSTEM 10/30/2003
K042493 ENDOCARDIAL SOLUTIONS, INC. ENSITE SYSTEM, MODEL EE3000 10/15/2004
K030129 ENDOCARDIAL SOLUTIONS, INC. MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 04/22/2003
K060980 ENDOTHELIX, INC. VENDYS MODEL 5000 B/BC 08/16/2007
K072919 ENDOTHELIX, INC. VENDYS, MODEL 6000 B B/C 11/02/2007
K063113 EP MEDSYSTEMS EP-WORKMATE 10/27/2006
K070706 EP MEDSYSTEMS EP-WORKMATE 04/11/2007
K032225 EP MEDSYSTEMS EP-WORKMATE WITH RPM SYSTEM 08/20/2003
K994011 EP MEDSYSTEMS, INC. EP MEDSYSTEMS, EP-WORKMATE 03/23/2000
K063277 EP MEDSYSTEMS, INC. MAPMATE 11/30/2006
K013349 EP TECHNOLOGIES, INC. ASTRONOMER PLUS SYSTEM 04/09/2002
K872928 FIDELITY MEDICAL, INC. LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH 01/06/1988
K012947 FLORENCE MEDICAL LTD. SMARTFLOW 10/02/2001
K020127 FLORENCE MEDICAL LTD. SMARTFLOW PULSE TRANSMISSION COEFFICIENT 02/14/2002
K030145 GALIX BIOMEDICAL INSTRUMENTATION, INC. GALIX WINTER 09/17/2003
K052977 GE HEALTHCARE DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES 11/22/2005
K052976 GE HEALTHCARE DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES 01/13/2006
K111200 GE HEALTHCARE MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM 10/12/2011
K061741 GE HEALTHCARE MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM 09/15/2006
K042148 GE MEDICAL SYST. INFORMATION TECHNOLOGIES HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES 12/03/2004
K031561 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES CARDIOSOFT/CASE CARDIAC TESTING SYSTEM 08/01/2003
K050093 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM 05/13/2005
K051026 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MARS HOLTER ANALYSIS WORKSTATION 07/19/2005
K093141 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MARS HOLTER ANALYSIS WORKSTATION 12/29/2009
K032577 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM 10/10/2003
K072502 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM 11/19/2007
K050614 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MUSE CARDIOLOGY INFORMATION SYSTEM 04/05/2005
K083639 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE 02/17/2009
K032513 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES T-WAVE ALTERNANS (TWA) ALGORITHM OPTION 10/30/2003
K103678 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM 02/16/2011
K130626 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS 05/01/2013
K132437 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MARS HOLTER ANALYSIS WORKSTATION 12/04/2013
K110132 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MUSE CARDIOLOGY INFORMATION SYSTEM 05/25/2011
K130155 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MUSE CARDIOLOGY INFORMATION SYSTEM 03/01/2013
K810750 GENERAL ELECTRIC CO. PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE 03/27/1981
K014108 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN MAC 5000 ECG ANALYSIS SYSTEM 01/10/2002
K992948 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN MAC-LAB SYSTEM 11/29/1999
K001305 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM 06/27/2000
K021366 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN MAC-LAB/CARDIOLAB EP/COMBOLAB 07/03/2002
K023380 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN T-WAVE ALTERMANS (TWA) ALGORITHM OPTION 12/03/2002
K051471 GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG CARDIODAY 06/29/2005
K130516 GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG CARDIODAY 08/23/2013
K070280 GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG CARDIODAY, VERSION 2.0 02/23/2007
K810731 GOULD, INC. MODEL IM1000 INTEGRATED MONITOR 03/27/1981
K953127 HEWLETT-PACKARD CO. ACCUSTRESS EXERCISE TESTING SYSTEM 02/29/1996
K905100 HEWLETT-PACKARD CO. HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST 01/15/1991
K780768 HEWLETT-PACKARD CO. MODEL 5621A INTERFACE 05/26/1978
K874171 HEWLETT-PACKARD CO. MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM 02/05/1988
K961009 HEWLETT-PACKARD CO. STRESSWRITER EXERCISE TESTING SYSTEM 06/17/1996
K896017 HIGHTECH VISION THE OPHTHIMUS SYSTEM 10/02/1990
K941762 HOGAN & HARTSON INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) 02/22/1995
K792677 HONEYWELL, INC. DATABASE MANAGEMENT & REPORTING SYSTEM 01/04/1980
K760767 HONEYWELL, INC. MEDDARS CARDIOVASCULAR DIAGNOSTIC SYSTEM 10/13/1976
K053369 HUNTLEIGH HEALTHCARE MEDILOG DARWIN HOLTER ANALYSIS 12/22/2005
K071911 INNOVISION A/S CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR 09/07/2007
K051907 INNOVISION A/S INNOCOR 03/02/2006
K770705 INSTRUMENTS FOR CARDIAC RESEARCH CARDIAC ACQUISITION SYSTEM, ICR 2001 06/02/1977
K900814 INTELLIMETRICS INSTRUMENT CORP. CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS 12/17/1990
K842339 INTL. MEDICAL, INC. COMPUSTRESS STRESS TESTING SYS 12/19/1984
K792525 IREX CORP. IREX CARDIOPLAN 12/27/1979
K091075 IRHYTHM TECHNOLOGIES, INC. ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM 07/21/2009
K142681 iRhythm Technologies, Inc. ZEUS (ZIO ECG Utilization Service) System 11/21/2014
K032519 ITAMAR MEDICAL ENDO PAT 2000 11/12/2003
K001852 ITAMAR MEDICAL (C.M.) 1997 LTD. PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE 02/21/2001
K945068 J-F MEDICAL SYSTEMS INTL., INC. OMEGA CARES SYSTEM 01/25/1996
K812354 KONTRON INSTRUMENTS, INC. KONTRON PMS 7000 09/25/1981
K800092 KT MEDICAL, INC. COMBISON COMPUTER 04/08/1980
K012825 LEV-EL, LTD. HEARTTRENDS 03/19/2002
K123466 LUMEDX HEALTHVIEW ECG MANAGER 12/20/2012
K922171 MARQUETTE ELECTRONICS, INC. CENTRA II ANALYSIS SYSTEM 12/28/1992
K855055 MARQUETTE ELECTRONICS, INC. PDS 9000 PATIENT DATA MGMT. SYSTEM 02/12/1986
K113515 MCKESSON ISRAEL LTD. HORIZON CARDIOLOGY ECG MANAGEMENT 03/16/2012
K133534 MCKESSON ISRAEL LTD. MCKESSON CARDIOLOGY ECG MOBILE 04/18/2014
K061905 MEDCON LTD. HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 11/08/2006
K050561 MEDCON LTD. WINDSURFER 05/04/2005
K033266 MEDICAL IMAGING APPLICATIONS LLC VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS 12/16/2004
K952846 MEDICOMP, INC. EPICARDIA 09/18/1995
K881770 MEDICOMP, INC. EPICARDIA LE/FD 05/31/1988
K091781 MEDIGUIDE, LTD. GUIDED MEDICAL POSITIONING SYSTEM (GMPS) 10/16/2009
K102905 MEDIGUIDE, LTD. GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II) 10/29/2010
K002869 MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES LOCALISA CARDIAC NAVIGATION SYSTEM 03/27/2001
K071348 MENNEN MEDICAL LTD. EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM 09/07/2007
K043564 MENNEN MEDICAL LTD. HORIZON ANGIO CATHLAB 01/27/2005
K070254 MENNEN MEDICAL LTD. HORIZON SE 04/19/2007
K081484 MENNEN MEDICAL LTD. HORIZON XVU 06/20/2008
K091165 MENNEN MEDICAL LTD. HORIZON XVU 08/07/2009
K922528 MICROMEDICAL INDUSTRIES, LTD. CMS SYSTEM 05/12/1995
K952969 NEW PRODUCT DEVELOPMENT, INC. EIDOS 5003 HOLTER SYSTEM 07/16/1996
K952164 NEW YORK HEART INSTRUMENTS, INC. EMI MODEL FFF-IA 05/10/1995
K942771 NON-INVASIVE MONITORING SYSTEMS, INC. RESPIEVENTS 02/13/1996
K012020 NON-INVASIVE MONITORING SYSTEMS, INC. RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC 08/21/2001
K001369 NON-INVASIVE MONITORING SYSTEMS, INC. RESPIEVENTS, VERSION 4.2 07/26/2000
K942852 NON-INVASIVE MONITORING SYSTEMS, INC. RESPITRACE PT 02/13/1996
K930564 NORTHEAST MONITORING, INC. HOLTER FOR WINDOWS 04/19/1995
K780468 NUMONICS CORP. CLINICAL GRAPHICS ANALYZER 06/19/1978
K950988 OMEGA MEDICAL SERVICES, INC. HOLTER 6000 01/04/1996
K002544 OXFORD INSTRUMENTS MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM 09/13/2000
K920295 OXFORD MEDILOG, INC. MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) 08/18/1992
K120855 PHILIPS HEALTHCARE INTELLISPACE ECG 06/29/2012
K121638 PHILIPS HEALTHCARE ST80I STRESS TEST SYSTEM 07/18/2012
K021495 PIE MEDICAL IMAGING B.V. QIVA 10/01/2002
K880879 PPG INDUSTRIES, INC. WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION 06/02/1988
K914577 PRECISION HEALTH CARE SYSTEMS, INC. RHYTHMSCAN PRECISION 6000 05/08/1992
K992703 PREMIER HEART, LLC. CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800 03/21/2000
K023112 PROBLEM SOLVING CONCEPTS, INC. PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 12/17/2002
K913193 PROTOCOL SYSTEMS, INC. MODEL 100 CENTRAL STATION 10/16/1991
K902716 PRUCKA ENGINEERING, INC. PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) 09/04/1990
K042799 PULSE BIOMEDICAL, INC. QRS-CARD CARDIOLOGY SUITE 10/22/2004
K032038 QUINTON, INC. PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 09/05/2003
K834567 QUINTON, INC. Q3000 04/30/1984
K892113 QUINTON, INC. Q5000 PC WORKSTATION 05/18/1989
K021906 QUINTON, INC. QUINTON Q-CATH, MODEL 000460 09/04/2002
K862740 QUINTON, INC. QUINTON Q.CATH 10/31/1986
K782072 QUINTON, INC. QUINTON STATUS 1000 02/23/1979
K042628 RADI MEDICAL SYSTEMS AB MODIFICATION TO: RADIANALYZER, MODEL 12711 01/19/2005
K123984 RADI MEDICAL SYSTEMS AB QUANTIEN MEASUREMENT SYSTEM 03/28/2013
K092105 RADI MEDICAL SYSTEMS AB RADIANALYZER XPRESS 10/09/2009
K022188 RADI MEDICAL SYSTEMS AB RADIANALYZER, MODEL 12710 10/03/2002
K951902 REYNOLDS MEDICAL LTD. PATHFINDER 700 HOLTER ANALYZER 07/15/1996
K130750 RHYTHMIA MEDICAL, INC RHYTHMIA MAPPING SYSTEM 07/22/2013
K042463 ROZINN ELECTRONICS, INC. HOLTER PLUS 09/22/2004
K973751 SCHILLER AMERICA, INC. MT-200 08/25/1998
K023015 SCHWARZER GMBH CARDIS 09/25/2002
K792135 SCI-PRO, INC. DYE CURVE EVALUATOR 01/11/1980
K002137 SIEMENS ELEMA AB CATHCOR DESKTOP 10/05/2000
K801810 SIEMENS ELEMA AB PACEMAKER PATIENT MGMT. SYSTEM 02/05/1981
K935043 SIEMENS MEDICAL ELECTRONICS SIEMENS CLINICAL WORK STATION 04/07/1995
K031970 SIEMENS MEDICAL SOLUTIONS USA, INC. INFINITY MEGACARE 09/09/2003
K865010 SIEMENS MEDICAL SOLUTIONS USA, INC. MICOR 07/06/1987
K920587 SIEMENS MEDICAL SOLUTIONS USA, INC. PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS 01/15/1993
K851637 SIEMENS MEDICAL SOLUTIONS USA, INC. SIRECUST 425, RESPECTIVELY SIRECUST 430 07/12/1985
K131812 SIEMENS MEDICAL SOLUTIONS, INC. SENSIS, SENSIS LITE 07/25/2013
K020440 SIEMENS MEDICAL SYSTEMS, INC. NEWCOR 12/03/2002
K914105 SOFTHEART, INC. CATHWRITER(TM) 02/26/1992
K921216 SOFTHEART, INC. OFF-LINE ANALYSIS SYSTEM 11/20/1992
K930639 SOFTHEART, INC. ON-LINE ANALYSIS SYSTEM 09/22/1993
K110779 SPACELABS HEALTHCARE SPACELABS SMART DISCLOSURE SYSTEM 04/19/2011
K110001 SPACELABS HEALTHCARE LTD. SPACELABS PATHFINDER SL HOLTER ANALYZER 06/14/2011
K063490 SPACELABS MEDICAL INC. SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 03/15/2007
K962930 SPACELABS MEDICAL, INC. SPACELABS MEDICAL ECG ANALYSIS SYSTEM 04/25/1997
K791776 SPACELABS, INC. ARRHYTHMIA II EDITOR 10/02/1979
K850627 SPACELABS, INC. SPACELABS-GENERAL SYSTEM LINK 05/28/1985
K070902 ST. JUDE MEDICAL MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 05/01/2007
K071818 ST. JUDE MEDICAL ENSITE FUSION DYNAMIC REGISTRATION TOOL 12/20/2007
K082467 ST. JUDE MEDICAL ENSITE FUSION DYNAMIC REGISTRATION TOOL 09/11/2008
K083328 ST. JUDE MEDICAL ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 05/22/2009
K101328 ST. JUDE MEDICAL ENSITE VELOCITY SYSTEM 07/14/2010
K110549 ST. JUDE MEDICAL ENSITE VELOCITY SYSTEM 05/05/2011
K130594 ST. JUDE MEDICAL ENSITE VELOCITY SYSTEM 05/03/2013
K130727 ST. JUDE MEDICAL ENSITE VELOCITY SYSTEM 08/29/2013
K141050 ST. JUDE MEDICAL ENSITE VELOCITY SYSTEM 06/06/2014
K101667 ST. JUDE MEDICAL ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) 07/02/2010
K112688 ST. JUDE MEDICAL ENSITE VELOCITY SYSTEM V.3.0 11/09/2011
K093942 ST. JUDE MEDICAL ENSITE VELOCITY SYSTEM V1.3 02/25/2010
K101419 ST. JUDE MEDICAL ENSITE VELOCITY SYSTEM, MODEL EE3000 06/11/2010
K093583 ST. JUDE MEDICAL EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE 12/15/2009
K092810 ST. JUDE MEDICAL EP-WORKMATE SYSTEM, VERSION 4.2 10/09/2009
K132073 ST. JUDE MEDICAL EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE 09/09/2013
K060954 ST. JUDE MEDICAL, INC.-ENDOCARDIAL SOLUTIONS MODIFICATION TO ENSITE SYSTEM, MODEL EE3000 04/21/2006
K120301 ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS MEDIGUIDE TECHNOLOGY 02/24/2012
K093092 STEREOTAXIS, INC. ODYSSEY WORKSTATION 01/21/2010
K110746 TOMTEC IMAGING SYSTEMS, GMBH 4D LV-ANALYSIS 3.0 05/24/2011
K103782 TOMTEC IMAGING SYSTEMS, GMBH 4D MV-ASSESSMENT 2.0 01/27/2011
K001592 TOMTEC IMAGING SYSTEMS, GMBH ECHOCOM, IMAGECOM, DOKUCOM 06/16/2000
K123295 TOPERA, INC. RHYTHM VIEW 04/24/2013
K133305 TOPERA, INC. RHYTHM VIEW WORKSTATION 12/16/2013
K110878 TOPERA, INC. RHYTHMVIEW (TM) 09/23/2011
K041031 US CLOVER CO. CARDIOSTATION-100 (CS-100) 01/26/2005
K864583 VASCULAR TECHNOLOGY INCORPORATED CARDIAC PERFORMANCE MONITOR 05/11/1987
K812739 VITALOG CORP. VITALOG PMS-8 MONITOR 12/29/1981
K043604 VIVOMETRICS, INC. LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE 04/29/2005
K011903 VIVOMETRICS, INC. LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE 04/12/2002
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K955015 ZYMED MEDICAL INSTRUMENTATION ZYMED HOLTER SCANNER MODEL 2010 03/18/1996


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