510kDecisions.com

FDA 510(k) Applications for Medical Device Product Code "BSZ"
(Gas-Machine, Anesthesia)

FDA 510(k) Number Applicant Device Name Decision Date
K052335 ACCUTRON, INC. ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA 11/23/2005
K992421 ACCUTRON, INC. GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 10/27/1999
K120075 ADVANCED INSTRUMENTATIONS, INC. AM-6000 ANESTHESIA MACHINE 01/26/2012
K854213 AGILENT TECHNOLOGIES, INC. ARI STANDARD ANESTHESIA RECORD 12/19/1985
K844563 AMERICAN ANESTHESIA, INC. PHOENIX ANESTHESIA MACHINE 06/14/1985
K853139 AMERICAN ANESTHESIA, INC. PHOENIX ANESTHESIA MACHINE 08/26/1985
K864644 AMERICAN ANESTHESIA, INC. PHOENIX-C ANESTHESIA MACHINE 03/09/1987
K864590 BEAR MEDICAL SYSTEMS, INC. AM1000 05/04/1987
K864589 BEAR MEDICAL SYSTEMS, INC. TRI-SERVICE OMV VAPORIZER 06/05/1987
K982137 BLEASE MEDICAL EQUIPMENT LTD. BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE 04/09/1999
K003251 BLEASE MEDICAL EQUIPMENT LTD. BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 05/23/2001
K041430 BLEASE MEDICAL EQUIPMENT LTD. BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 10/07/2004
K001727 BLEASE MEDICAL EQUIPMENT LTD. MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES 08/09/2000
K051629 BLEASE USA, INC. BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 09/23/2005
K012446 CHARLES A. SMITH OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI 10/03/2001
K000859 CHARLES A. SMITH OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1 08/23/2000
K760228 CHEMETRON HEALTH SYSTEMS ANESTHESIA MACHINE, CHEMETRON 08/06/1976
K101439 CODONICS, INC. CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P 02/07/2011
K855022 COMPUTERIZED ANESTHESIA SYSTEMS, INC. COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK 02/28/1986
K123211 DATASCOPE CORP., PATIENT MONITORING DIVISION A5 ANESTHESIA DELIVERY SYSTEM 02/14/2013
K080175 DATASCOPE CORP., PATIENT MONITORING DIVISION NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 06/09/2008
K923172 DATEX DIVISION INSTRUMENTARIUM CORP. ANAESTHESIA RECORD KEEPER 08/09/1994
K945234 DATEX DIVISION INSTRUMENTARIUM CORP. AS/3 MEMORY MODULE, M0MEM 01/27/1995
K884991 DATEX DIVISION INSTRUMENTARIUM CORP. CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN 06/06/1989
K933285 DATEX DIVISION INSTRUMENTARIUM CORP. DATEX AS/3 TM ANAESTHESIA MONITOR 11/14/1994
K973985 DATEX-ENGSTROM, INC. AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) 10/30/1998
K122445 DATEX-OHMEDA AESPIRE 7900, AESPIRE VIEW 10/12/2012
K032803 DATEX-OHMEDA DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM 03/10/2004
K071142 DATEX-OHMEDA GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM 06/06/2007
K131945 DATEX-OHMEDA GE DATEX-OHMEDA AVANCE CS2 08/08/2013
K092864 DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C AESPIRE 7900, AESPIRE VIEW 01/12/2010
K143530 Datex-Ohmeda, Inc. Aespire View 4/24/2015
K993410 DATEX-OHMEDA, INC. DATES-OHMEDA AESTIVA SMARTVENT MRI 04/25/2000
K000706 DATEX-OHMEDA, INC. DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR 05/11/2000
K050626 DATEX-OHMEDA, INC. GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM 03/25/2005
K050055 DATEX-OHMEDA, INC. GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM 02/04/2005
K073707 DATEX-OHMEDA, INC. GE DATEX-OHMEDA AISYS 01/30/2008
K090233 DATEX-OHMEDA, INC. GE DATEX-OHMEDA AISYS 03/05/2009
K061609 DATEX-OHMEDA, INC. GE DATEX-OHMEDA AISYS 06/27/2006
K110213 DATEX-OHMEDA, INC. GE DATEX-OHMEDA AISYS 07/20/2011
K042154 DATEX-OHMEDA, INC. GE DATEX-OHMEDA AISYS CARESTATION 08/31/2004
K132530 DATEX-OHMEDA, INC. GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) 12/20/2013
K081844 DATEX-OHMEDA, INC. GE DATEX-OHMEDA AVANCE 08/29/2008
K112722 DATEX-OHMEDA, INC. GE DATEX-OHMEDA AVANCE 12/16/2011
K123125 DATEX-OHMEDA, INC. GE DATEX-OHMEDA AVANCE CS2 02/06/2013
K050676 DATEX-OHMEDA, INC. GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) 04/12/2005
K040743 DATEX-OHMEDA, INC. MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM 04/22/2004
K884802 DENTSPLY INTL. CAVENDISH 460/680 ANESTHESIA MACHINE 08/01/1989
K862085 DIATEK, INC. ARKIVE (TM) 01/12/1987
K872178 DIATEK, INC. MODIFICATION TO ARKIVE(TM) 01/27/1988
K062388 DOCUSYS ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM 02/22/2007
K072884 DRAEGER MEDICAL AG & CO. KG FABIUS MRI 07/30/2008
K081447 DRAEGER MEDICAL AG & CO. KG FOURTH GAS MODULE WITH CO2 FOR PRIMUS US "APOLLO" 10/08/2008
K133886 DRAEGER MEDICAL GMBH PERSEUS A500 06/20/2014
K103035 DRAEGER MEDICAL GMBH SMARTPILOT VIEW MODEL MK04500 03/28/2012
K864806 DRAEGER MEDICAL, INC. ANESTHESIA RECORDER 01/15/1987
K851621 DRAEGER MEDICAL, INC. BOOM ARM 05/10/1985
K833147 DRAEGER MEDICAL, INC. CENTRALERT 12/16/1983
K771989 DRAEGER MEDICAL, INC. CONTINUOUS FLOW ANESTHESIA MACHINE 11/15/1977
K011404 DRAEGER MEDICAL, INC. FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS 02/22/2002
K042086 DRAEGER MEDICAL, INC. FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM 08/31/2004
K042419 DRAEGER MEDICAL, INC. FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM 10/08/2004
K031400 DRAEGER MEDICAL, INC. FABIUS TIRO ANESTHESIA SYSTEM 07/15/2003
K983635 DRAEGER MEDICAL, INC. JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN 01/11/1999
K030624 DRAEGER MEDICAL, INC. MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM 03/17/2004
K041622 DRAEGER MEDICAL, INC. MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM 07/08/2004
K822218 DRAEGER MEDICAL, INC. NARKOMED 2A ANESTHESIA MACHINE 09/07/1982
K900328 DRAEGER MEDICAL, INC. NARKOMED 2B ANESTHESIA SYSTEM 02/01/1990
K864447 DRAEGER MEDICAL, INC. NARKOMED 2B ANESTHESIA SYSTEM 01/27/1987
K930351 DRAEGER MEDICAL, INC. NARKOMED 2C ANESTHESIA SYSTEM 06/22/1993
K900329 DRAEGER MEDICAL, INC. NARKOMED 3 ANESTHESIA SYSTEM 02/01/1990
K853435 DRAEGER MEDICAL, INC. NARKOMED 3 ANESTHESIA SYSTEM 01/22/1986
K861170 DRAEGER MEDICAL, INC. NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED) 04/01/1986
K901713 DRAEGER MEDICAL, INC. NARKOMED 4 ANESTHESIA SYSTEM 07/09/1990
K980553 DRAEGER MEDICAL, INC. NARKOMED 6000 MODEL NUMBER NM6000 08/04/1998
K033498 DRAEGER MEDICAL, INC. NARKOMED 6400, MODEL NM6400 04/26/2004
K770554 DRAEGER MEDICAL, INC. NARKOMED ANESTHESIA MACHINE 03/30/1977
K963994 DRAEGER MEDICAL, INC. NARKOMED GS ANESTHESIA SYSTEM 03/19/1997
K971425 DRAEGER MEDICAL, INC. NARKOMED M ANESTHESIA SYSTEM (M) 09/10/1997
K001488 DRAEGER MEDICAL, INC. NARKOMED MRI , NM-MRI 06/09/2000
K972848 DRAEGER MEDICAL, INC. NARKOMED MRI ANESTHESIA SYSTEM 10/30/1997
K022031 DRAEGER MEDICAL, INC. NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 08/29/2002
K003579 DRAEGER MEDICAL, INC. NARKOMED MRI-2, MODEL NM-MRI-2 01/22/2001
K974193 DRAEGER MEDICAL, INC. NARKOMED ULTRASONIC FLOW SENSOR 01/28/1998
K900937 DRAEGER MEDICAL, INC. O.R. DATA MANAGER 04/05/1990
K945463 DRAEGER MEDICAL, INC. PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM 02/03/1995
K973949 DRAEGER MEDICAL, INC. PERIOPERATIVE DATA MANAGEMENT SYSTEM 02/06/1998
K042607 DRAEGER MEDICAL, INC. PRIMUS US 11/26/2004
K132903 DRE MEDICAL, INC. DRE VENTURA 07/01/2014
K771057 FOREGGER ANESTHESIA MACHINE 07/05/1977
K833151 FRASER HARLAKE, INC. BOYLE SYSTEM ANESTHESIA GAS MACHINE 11/14/1983
K802591 G. DUNDAS CO. MODEL 5460 + 5480 POP-OFF VALVES 11/12/1980
K090892 GE HEALTHCARE FINLAND OY GE DATEX-OHMEDA S/5 ADU CARESTATION 04/30/2009
K081941 GE HEALTHCARE FINLAND OY NAVIGATOR APPLICATIONS SUITE 08/07/2008
K083098 GE HEALTHCARE FINLAND OY NAVIGATOR APPLICATIONS SUITE 04/01/2009
K071097 GE HEALTHCARE FINLAND OY NAVIGATOR APPLICATIONS SUITE 10/10/2007
K102389 GE HEALTHCARE FINLAND OY NAVIGATOR APPLICATIONS SUITE 06/10/2011
K965160 HEWLETT-PACKARD GMBH HP ORVUE INTRA-OP (M2510A) 09/11/1997
K963481 HEYER AMERICA, INC. ANODYNE CC 08/11/1997
K001988 HEYER AMERICA, INC. MODULAR 02/05/2001
K000995 HEYER AMERICA, INC. NARKOMAT, MODEL 2000 10/11/2000
K923519 HOSPITRONIC SENSOR GUI 12/08/1992
K033026 MALLARD MEDICAL, INC. MALLARD MODEL 3000 ANESTHESIA MACHINE 09/03/2004
K133958 MAQUET CRITICAL CARE AB FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 03/20/2014
K112114 MAQUET CRITICAL CARE AB MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 01/13/2012
K102182 MAQUET CRITICAL CARE AB MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 05/09/2011
K884879 MATRIX MEDICA, INC. CENTURION(TM) MIXER 02/09/1989
K945722 MATRX MEDICAL, INC. MATRX MDM, RA 12/29/1994
K113633 MCKESSON TECHNOLOGIES INC. MCKESSON ANESTHESIA CARE 04/20/2012
K934669 MEDELEC LTD. ARC 04/26/1994
K971030 MEDICAL AND INDUSTRIAL EQUIPMENT MIE FALCON, DATEX ENGSTROM FLEXIMA II 11/12/1997
K981845 MEDICAL INDUSTRIAL EQUIPMENT HAWK ANAESTHESIA INDUCTION UNIT 11/03/1998
K841370 MEDIMEX, INC. KMA-1300F 06/07/1984
K102471 MINDRAY DS USA, INC. AS3700 ANESTHSIA DELIVERY SYSTEM 02/11/2011
K902962 MODULAR INSTRUMENTS, INC. LIFELOG(TM) 09/04/1990
K801100 NARCO MCKESSON CO. ANALOR FOUR-DENTAL MODEL 05/28/1980
K801103 NARCO MCKESSON CO. COMPALOR-DENTAL MODEL 05/28/1980
K801102 NARCO MCKESSON CO. COMPALOR-ORAL SURGERY MODEL 06/17/1980
K790456 NARCO MCKESSON CO. SERIES 7000 03/23/1979
K781492 NARCO MCKESSON CO. SERIES 7000 GAS MACHINE 09/11/1978
K830680 NARCO SCIENTIFIC AIR-SHIELDS VENTIMETER VENTILATOR-CONTR 04/08/1983
K060193 OCEANIC MEDICAL PRODUCTS, INC. MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 04/10/2006
K010613 OCEANIC MEDICAL PRODUCTS, INC. MAGELLAN-2200, MODEL 1 10/12/2001
K072420 OCEANIC MEDICAL PRODUCTS, INC. MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE 01/22/2008
K841274 OHIO MEDICAL PRODUCTS BAG-TO-VENTILATOR SELECTOR VALVE 04/13/1984
K833335 OHIO MEDICAL PRODUCTS MODULUS II ANESTHESIA GAS MACHINE 11/14/1983
K771479 OHIO MEDICAL PRODUCTS NITROX 30 - ANESTHETIC GAS PROPORTIONER 11/07/1977
K791530 OHIO MEDICAL PRODUCTS OHIO MODULAR ANESTHESIA GAS MACHINE 09/19/1979
K840356 OHIO MEDICAL PRODUCTS OHIO UNITROL II ANESTHESIA GAS MACHINE 04/20/1984
K913791 OHMEDA ANESTHESIA SYSTEMS THERAPY GROUP OHMEDA 7800 ANESTHESIA VENTILATOR 04/08/1993
K925580 OHMEDA ANESTHESIA SYSTEMS THERAPY GROUP OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD 06/02/1993
K862831 OHMEDA MEDICAL MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM 08/20/1986
K863207 OHMEDA MEDICAL OHMEDA 'B' SERIES GAS DELIVERY SYSTEM 10/30/1986
K844012 OHMEDA MEDICAL OHMEDA ANESTHESIA RECORD KEEPER 10/18/1984
K965041 OHMEDA MEDICAL OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM 06/17/1997
K921742 OHMEDA MEDICAL OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY 05/26/1993
K973896 OHMEDA MEDICAL OHMEDA EXCEL 3000 ANESTHESIA SYSTEM 04/21/1998
K946127 OHMEDA MEDICAL OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM 10/08/1996
K893780 OHMEDA MEDICAL OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM 04/19/1990
K844849 OHMEDA MEDICAL OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA 05/15/1985
K894309 OHMEDA MEDICAL OHMEDA MODULUS CD ANESTHESIA SYSTEM 10/06/1989
K901119 OHMEDA MEDICAL OHMEDA MODULUS CD ANESTHESIA SYSTEM 05/18/1990
K905635 OHMEDA MEDICAL OHMEDA MODULUS CD ANESTHESIA SYSTEM 05/03/1991
K875350 OHMEDA MEDICAL OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM 03/24/1988
K850648 OHMEDA MEDICAL OHMEDA PAC PORTABLE ANESTHESIA SYSTEM 07/01/1985
K901117 OHMEDA MEDICAL OHMEDA UNIVERSAL PAC 09/07/1990
K890410 OHMEDA MEDICAL REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE 04/12/1989
K882489 OHMEDA MEDICAL REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS 07/08/1988
K131790 ORICARE, INC. A9800 ANESTHESIA WORKSTATION 05/09/2014
K852175 PATIENT DATA SYSTEMS PATIENT DATA SYSTEMS CVA 09/06/1985
K061102 PENLON LTD. PRIMA ANAESTHESIA MACHINE 07/28/2006
K803052 PENLON, INC. NUFFIELD ANESTHESIA VENTILATOR SER. 400 01/07/1981
K844008 PENLON, INC. PENLON AM1000 ANAESTHESIA MACHINE 03/12/1985
K122063 PHILIPS ANESTHESIA CARE INTELLISAVE AX700 ANESTHESIA SYSTEM 08/02/2013
K083413 PHILIPS MEDICAL SYSTEMS COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM 12/18/2008
K030939 PHILIPS MEDICAL SYSTEMS PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE 07/15/2003
K930492 PREMIER ANESTHESIA SYSTEMS IDACARE ANESTHESIA MANAGEMENT WORKSTATIN 06/18/1993
K844421 PURITAN BENNETT CORP. FOREGGER DOME VALVES 01/14/1985
K050883 SAFER SLEEP LLC SAFERSLEEP SYSTEM 11/04/2005
K903135 SHASTA LOGIC CORP. CLINI-CALC 01/14/1991
K142552 ShenZhen Mindray Bio-Medical Electronics Co., Ltd A7 Anesthesia System 1/23/2015
K001315 SIEMENS ELEMA AB MODIFICATION TO KION ANESTHESIA SYSTEM 05/26/2000
K903991 SIEMENS LIFE SUPPORT SYSTEMS PCM ANESTHESIA 02/25/1991
K973971 SIEMENS MEDICAL SOLUTIONS USA, INC. KION ANESTHESIA SYSTEM 09/13/1999
K981530 SPACELABS MEDICAL, INC. SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM 11/20/1998
K003663 SPACELABS MEDICAL, INC. SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE 06/28/2001
K800801 SPICA, INC. ANALGESIA UNITS, OXYGEN & NITRATE DEVICE 05/28/1980
K970163 TECHNICAL MEDICAL PRODUCTS, INC. ALPHA MX (20)/ULTRA PC (30) 12/10/1997
K920944 TREK MEDICAL PRODUCTS, INC. FTS-200 GAS SYSTEM 05/29/1992
K935546 VITAL SIGNS, INC. MAC/IV SEDATION KIT 06/13/1994
K830161 W.E. LEDER ENTERPRISES, INC. ANESTHESIA APATATUS #D-25 03/09/1983
K830160 W.E. LEDER ENTERPRISES, INC. ANESTHESIA APPARATUS #FO 20S 03/09/1983
K830159 W.E. LEDER ENTERPRISES, INC. ANESTHESIA APPARATUS PH-35 03/09/1983


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