FDA 510(k) Applications for Medical Device Product Code "DPW"
(Flowmeter, Blood, Cardiovascular)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K972213 | ALAN S. LEE | MS-700 | 03/13/1998 |
| K031153 | ARROW INTL., INC. | MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 | 11/25/2003 |
| K013803 | BIOSONIX LTD. | FLOWGUARD DEVICE | 02/13/2002 |
| 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 |
| 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 |
| K031706 | DELTEX MEDICAL | CARDIOQ, MODEL 9051-7005 | 08/06/2003 |
| K111542 | DELTEX MEDICAL LIMITED | DELTEX MEDICAL CARDIOQ EDM | 10/20/2011 |
| K150347 | DELTEX MEDICAL LIMITED | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ | 07/24/2015 |
| 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 |
| K040909 | EM-TEC GMBH | SONO TT ULTRASONIC FLOWCOMPUTER | 04/20/2004 |
| K111730 | EM-TEC GMBH | SONOTT FLOWLAB(R) | 01/06/2012 |
| K222242 | Flosonics Medical | FloPatch FP120 | 12/09/2022 |
| K223843 | Flosonics Medical | FloPatch FP120 | 05/03/2023 |
| K191388 | Flosonics Medical (r/a 1929803 Ontario Corp.) | FloPatch (FP110) | 06/21/2019 |
| K200337 | Flosonics Medical (r/a 1929803 Ontario Corp.) | FloPatch (FP120) | 03/24/2020 |
| K013376 | HEMEDEX INCORPORATED | QFLOW 500 PERFUSION MONITORING SYSTEM | 05/08/2002 |
| K183574 | Huntleigh Healthcare Ltd | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | 09/06/2019 |
| K002186 | HUNTLEIGH HEALTHCARE, INC. | VASCULAR ASSIST | 05/02/2001 |
| K984338 | JOSTRA BENTLEY | JOSTRA HL-20 TWIN PUMP | 08/19/1999 |
| 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 |
| K201114 | Koven Technology, Inc. | Bidop 7 | 01/05/2021 |
| K031931 | KOVEN TECHNOLOGY, INC. | ECHO SOUNDER EX-101EX 8 MHZ | 02/13/2004 |
| 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 |
| K192966 | Laser Associated Sciences, Inc. | FlowMet | 01/10/2020 |
| K182494 | Laser Associated Sciences, Inc. | FlowMet-R | 02/27/2019 |
| 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 |
| K973198 | MEDICARD LTD. | VGF-7 VASCULAR GRAFT FLOWMETER | 10/14/1998 |
| 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 |
| K102433 | MOOR INSTRUMENTS LTD. | MOORVMS-PRES PRESSURE CUFF CONTROLLER | 11/18/2010 |
| K050088 | NEOPROBE CORP. | QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER | 02/08/2005 |
| 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 |
| K974285 | PERIMED, INC. | PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT | 05/28/1998 |
| K212065 | Remington Medical, Inc. | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | 10/07/2021 |
| K211589 | Remington Medical, Inc. | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger | 01/27/2022 |
| K181269 | Rfpi | iCertainty | 12/14/2018 |
| 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 |
| K213974 | Synovis Micro Companies Alliance, Inc. | GEM FLOW COUPLER Monitor (GEM1020M-2) | 04/20/2022 |
| K030505 | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CAPIOX CARDIOTOMY RESERVOIR | 05/14/2003 |
| 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 |
| K140740 | TRANSONIC SYSTEMS, INC. | TRANSONIC TISSUE PERFUSION MONITOR | 07/23/2015 |
| K110438 | VASAMED, INC. | SENSILASE PAD-IQ | 05/04/2011 |
| 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 |
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