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FDA 510(k) Application Details - K992133

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K992133
Device Name Ventilator, Continuous, Facility Use
Applicant NEWPORT MEDICAL INSTRUMENTS, INC.
760 WEST 16TH ST., BLDG. N
COSTA MESA, CA US
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Contact ROBERT W DICK
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 06/23/1999
Decision Date 08/04/2000
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review N



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