FDA 510(k) Applications for Medical Device Product Code "DPW"
(Flowmeter, Blood, Cardiovascular)

FDA 510(k) Number Applicant Device Name Decision Date
K872068 ADVANCED TECHNOLOGY LABORATORIES, INC. HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD 09/30/1987
K972213 ALAN S. LEE MS-700 03/13/1998
K912562 APPLIED BIOMETRICS, INC. ABCOM 2000 01/09/1992
K031153 ARROW INTL., INC. MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 11/25/2003
K904317 AVALON TECHNOLOGY CORP. AVALON GENERAL PURPOSE SCANNER, PREVIEW GP 02/13/1991
K811615 BACH-SIMPSON LTD. BACH-SIMPSON MODEL BVM30 08/13/1981
K811616 BACH-SIMPSON LTD. BACH-SIMPSON MODEL TS266 08/13/1981
K013803 BIOSONIX LTD. FLOWGUARD DEVICE 02/13/2002
K862841 BIOSOUND, INC. HIGH VELOCITY CW DOPPLER SYSTEM 11/10/1986
K840169 BIOTRONICS INSTRUMENTS PHONOANGIOGRAPHIC SPECTRAL ANALYZER 03/01/1985
K925524 CARDIOMETRICS, INC. CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) 08/23/1993
K905411 CARDIOMETRICS, INC. FLOWIRE AND FLOMAP 03/29/1991
K882593 CARDIOMETRICS, INC. MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM 08/29/1988
K901733 CARDIOMETRICS, INC. MODIFIED FLOCATH PULMONARY ARTERY CATHETER 07/16/1990
K041180 CARDIOSONIX, LTD. QUANTIX OR VESSEL STABILIZER DEVICE 06/07/2004
K023431 CARDIOSONIX, LTD. QUANTIX/ND DEVICE 11/13/2002
K030357 CARDIOSONIX, LTD. QUANTIX/OR DEVICE 08/20/2003
K820272 CAROLINA MEDICAL ELECTRONICS CLINIFLOW II, #701, ELECTROMAGN. BLD. SY 03/12/1982
K810561 CAROLINA MEDICAL ELECTRONICS DOPSCAN MODEL 1050 04/10/1981
K110347 COOK VASCULAR, INC. DOPPLER MONITOR 03/16/2011
K051145 CRITISENSE LTD. CRITIVIEW 01/18/2006
K062977 CRITISENSE LTD. CRITIVIEW, MODEL CRV3 02/28/2007
K761288 D. EUGENE HOKANSON P-1 ULTRASONIC ARTERIOGRAPH 12/28/1976
K031706 DELTEX MEDICAL CARDIOQ, MODEL 9051-7005 08/06/2003
K951369 DELTEX MEDICAL EDM 11/07/1995
K111542 DELTEX MEDICAL LIMITED DELTEX MEDICAL CARDIOQ EDM 10/20/2011
K132139 DELTEX MEDICAL LIMITED DELTEX MEDICAL CARDIOQ-EDM+ 10/10/2013
K172457 Deltex Medical Limited Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM 06/28/2018
K150347 DELTEX MEDICAL LIMITED Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ 07/24/2015
K861023 DIAGNOSTIC ELECTRONICS CORP. DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER 11/17/1986
K860651 DIAGNOSTIC ELECTRONICS CORP. MICRON, MICROVASCULAR DOPPLER 07/18/1986
K904792 DIAGNOSTIC ULTRASOUND CORP. DIAGNOSTIC ULTRASOUND VERSADOPP 1000 01/28/1991
K791418 DIAGNOSTICS INTL. VASCULIZER 10/04/1979
K040909 EM-TEC GMBH SONO TT ULTRASONIC FLOWCOMPUTER 04/20/2004
K111730 EM-TEC GMBH SONOTT FLOWLAB(R) 01/06/2012
K901335 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER 08/10/1990
K871490 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION 12/07/1987
K013376 HEMEDEX INCORPORATED QFLOW 500 PERFUSION MONITORING SYSTEM 05/08/2002
K913827 HEWLETT-PACKARD CO. MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG 11/19/1991
K902088 HEWLETT-PACKARD CO. MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND 08/08/1990
K002186 HUNTLEIGH HEALTHCARE, INC. VASCULAR ASSIST 05/02/2001
K896613 IMEX MEDICAL SYSTEMS, INC. "FLAT VASCULAR PROBE" 02/16/1990
K882138 IMEX MEDICAL SYSTEMS, INC. IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER 11/07/1988
K910049 INTERSPEC, INC. INTERSPEC APOGEE, MODIFICATION 04/29/1991
K811246 IREX CORP. DOPPLER ULTRASOUND BLOOD FLOWMETER 08/12/1981
K984338 JOSTRA BENTLEY JOSTRA HL-20 TWIN PUMP 08/19/1999
K892707 KOVEN AND ASSOC., INC. DVM-4200 BLOOD FLOWMETER 07/28/1989
K903026 KOVEN AND ASSOC., INC. ES-1000SP II SMART DOP 02/26/1991
K915550 KOVEN AND ASSOC., INC. MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR 12/10/1992
K922669 KOVEN AND ASSOC., INC. MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW 01/29/1993
K920333 KOVEN AND ASSOC., INC. SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR 01/22/1993
K010452 KOVEN TECHNOLOGY, INC. BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T 02/12/2002
K954397 KOVEN TECHNOLOGY, INC. BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY 03/29/1996
K031931 KOVEN TECHNOLOGY, INC. ECHO SOUNDER EX-101EX 8 MHZ 02/13/2004
K942613 KOVEN TECHNOLOGY, INC. SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR 12/23/1994
K050601 KOVEN TECHNOLOGY, INC. SMARTDOP 45 VASCULAR DOPPLER 04/15/2005
K982986 KOVEN TECHNOLOGY, INC. TUBING BLOOD FLOW METER MODEL NUMBER HD-800 11/24/1998
K874885 LAWRENCE MEDICAL SYSTEMS, INC. LAWRENCE L3000 CARDIAC OUTPUT MONITOR 02/05/1988
K920844 LISCA DEVELOPMENT AB PIM 1.0 LASER DOPPLER PERFUSION IMAGER 07/21/1992
K840522 LITTON MEDICAL ELECTRONICS RECOMED BLOOD-FLOW METER H236-052-02 05/16/1985
K930227 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MS DISPOSABLE RIGID DOPPLER PROBE 09/16/1993
K844631 MEDEX, INC. PERIFLUX PF-2 02/20/1985
K040228 MEDI-STIM A/S MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 04/29/2004
K102595 MEDI-STIM ASA MEDISTIM VERIQC SYSTEM 12/27/2010
K770115 MEDICAL ELECTRONIC DEVICES, INC. ARTERIAL DIAGNOSTIC UNIT (ADU) 02/01/1977
K801802 MEDICAL TESTING SYSTEM, INC. ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE 01/02/1981
K973198 MEDICARD LTD. VGF-7 VASCULAR GRAFT FLOWMETER 10/14/1998
K854500 MEDPACIFIC CORP. HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER - 02/26/1986
K760751 MEDSONICS CONTINUOUS WAVE DOPPLER 10/13/1976
K780302 MEDTRONIC VASCULAR BLOOD FLOWMETER SYSTEM 04/21/1978
K853952 METRIFLOW, INC. METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME 01/05/1987
K970211 MICRO WEISS ELECTRONICS MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR 04/30/1998
K970139 MICRO WEISS ELECTRONICS MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO 04/30/1998
K860766 MILLAR INSTRUMENTS, INC. MILLAR PULSED DOPPLER VELOCIMETER 07/29/1986
K102433 MOOR INSTRUMENTS LTD. MOORVMS-PRES PRESSURE CUFF CONTROLLER 11/18/2010
K811376 NARCO BIO-SYSTEMS ULTRASONIC QFM SYSTEM 1000 08/13/1981
K050088 NEOPROBE CORP. QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER 02/08/2005
K820742 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100 04/15/1982
K894631 NIHON KOHDEN AMERICA, INC. NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW. 01/19/1990
K812005 NUCLEAR PACIFIC, INC. CAPILLARY PERFUSION MONITOR #LD5000 02/04/1982
K040654 OPTICAL SENSORS, INC. SENSILASE PAD 3000 06/04/2004
K131854 OR-NIM MEDICAL LTD. CEROX 09/13/2013
K150268 OR-NIM MEDICAL LTD. CerOX 11/06/2015
K152930 PERIMED AB PeriFlux6000 05/05/2016
K011899 PERIMED AB PF 5050 PRESSURE UNIT, MODEL PF 5050 11/06/2001
K890828 PERIMED, INC. PERIFLUX PF3 06/20/1989
K922368 PERIMED, INC. PERIFLUX PF4001 LASER DOPPLER FLOWMETER 02/03/1993
K974285 PERIMED, INC. PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT 05/28/1998
K932068 PERIMED, INC. PERITEMP PF 4005 HEATER 12/07/1993
K903625 PERIPHERAL SYSTEMS GROUP DOPPLER NEEDLE AND FLOW MONITOR 11/07/1990
K992387 ROSSMAX INTERNATIONAL LTD. ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100 08/03/1999
K992388 ROSSMAX INTERNATIONAL LTD. ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200 08/03/1999
K973078 SEIN ELECTRONICS CO., LTD. WRIST BLOOD PRESSURE METER MODEL SE-330 05/20/1999
K972798 SOMETEC, INC. DYNEMO 3000 02/24/1998
K862720 SONICAID, INC. VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES 11/17/1986
K800151 SYVA CO. EMIT TOBRAMYCIN CONTROL 02/05/1980
K850137 TECA, INC. TECA TC2-64 TRANSCRANIAL DOPPLER 08/14/1985
K030505 TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX CARDIOTOMY RESERVOIR 05/14/2003
K922034 TITRONICS MEDICAL INSTRUMENTS, INC. LV-20 VOLUMETER, 20 MHZ DOPPLER BLOOD FLOW METER 05/18/1993
K033424 TRANSONIC SYSTEMS, INC. ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 12/11/2003
K112657 TRANSONIC SYSTEMS, INC. AUREFLO MONITORING SYSTEM 12/21/2011
K872048 TRANSONIC SYSTEMS, INC. TRANSONIC FLOWMETER 06/21/1988
K140740 TRANSONIC SYSTEMS, INC. TRANSONIC TISSUE PERFUSION MONITOR 07/23/2015
K903633 TRANSTRACHEAL SYSTEMS ADVANCE LASER FLOWMETER, ALF 21 10/09/1990
K851057 TSI, INC. LASERFLO BLOOD PERFUSION MONITOR 403 06/24/1985
K896515 TSI, INC. LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2 02/13/1990
K864259 TSI, INC. MODIFIED LASERFLO BLOOD PERFUSION MONITOR 02/20/1987
K875179 TSI, INC. MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A 09/19/1988
K110438 VASAMED, INC. SENSILASE PAD-IQ 05/04/2011
K911763 VASAMEDICS, L.L.C. LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) 08/13/1991
K951486 VASAMEDICS, L.L.C. MODEL PV2000 VASCULAR MICROLABORATORY 06/29/1995
K912446 VASAMEDICS, L.L.C. MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 12/12/1991
K052209 VASCULAR CONTROL SYSTEMS, INC VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 09/06/2005
K031091 VASCULAR TECHNOLOGY INCORPORATED VTI 20 MHZ GATED DOPPLER 04/23/2003
K082870 VASCULAR TECHNOLOGY INCORPORATED VTI INTRAOPERATIVE DOPPLER SYSTEMS 10/28/2008
K992529 VITAL MEDICAL LTD. TISSUE SPECTROSCOPE 11/17/2000
K863210 WATERS INSTRUMENTS, INC. VELCOM-100 11/26/1986
K901015 WRIGHT MEDICAL CORP. WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC 11/05/1990
K821373 XOMED, INC. XOMED PATENCY MONITOR 07/08/1982
K921377 ZERTL MEDICAL, INC. P/METER 10/12/1993


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