FDA 510(k) Applications for Medical Device Product Code "DRQ"
(Amplifier And Signal Conditioner, Transducer Signal)

FDA 510(k) Number Applicant Device Name Decision Date
K870728 A & D ENGINEERING, INC. TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 03/27/1987
K172216 ACIST Medical Systems, Inc. ACIST RXi Mini System 08/18/2017
K894295 ASTRO-MED, INC. ASTRO-MED ASC-951 PRESSURE PROCESSOR 01/18/1990
K913875 BARD ELECTROPHYSIOLOGY BARD(R) BIOPOTENTIAL AMPLIFIER II 11/27/1991
K152693 BOSTON SCIENTIFIC CORPORATION CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels 10/21/2015
K150235 BOSTON SCIENTIFIC CORPORATION CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels 04/22/2015
K780571 C-V MONITORS CORP. BLOOD PRESSURE MODULE 05/09/1978
K901358 C.R. BARD, INC. BARD BIOPOTENTIAL AMPLIFIER II 05/09/1990
K050006 C.R. BARD, INC. BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO 05/27/2005
K864320 CORDIS CORP. SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE 02/20/1987
K761017 DATASCOPE CORP. PRESSURE MODULE (MODEL P3) 11/15/1976
K050974 Draeger Medical Systems, Inc. DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS 04/29/2005
K033807 Draeger Medical Systems, Inc. INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER 03/09/2004
K885252 EP TECHNOLOGIES, INC. MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 01/13/1989
K870783 FISHER IMAGING CORP. BPA CARDIOVASCULAR PRESSURE AMPLIFIER 04/27/1987
K830914 HONEYWELL, INC. EXTERNAL VALVE FUNCTION BLOCK 08/12/1983
K800488 KENT BARKER & ASSOC. SURGERY DISPLAY SYSTEM 04/16/1980
K910905 LIFE SCIENCES MANUFACTURING, INC. SFA-II MICROPROCESSOR-CONTROLLED MODULE 07/24/1991
K770247 MENNEN GREATBATCH ELECTONICS D.C. AMPLIFIER MODULE 02/14/1977
K913110 MICROWAVE MEDICAL SYSTEMS, INC. PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED 10/10/1991
K013205 MILLAR INSTRUMENTS, INC. MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 07/02/2002
K010640 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER 03/20/2001
K020277 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER 02/19/2002
K803011 SORENSEN RESEARCH DISPOSABLE DIAPHRAGM DONE 12/31/1980
K802961 SORENSEN RESEARCH TRANSDUCER DOME, CAT.#SD-101 12/31/1980
K904749 TRANSTRACHEAL SYSTEMS TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 03/01/1991
K792190 WILTON WEBSTER LABORATORIES MODEL CF-300 THREE CHANNEL FLOW METER 11/21/1979


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