FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K021874 |
ABBOTT LABORATORIES |
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 |
07/12/2002 |
K961661 |
ABBOTT LABORATORIES |
OXIMETRIX 4 COMPUTER SYSTEM |
03/04/1997 |
K970784 |
ALEXANDER MFG. CO. |
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T) |
05/14/1997 |
K092219 |
APPLIED PHYSIOLOGY PTY LTD. |
NAVIGATOR CLINICAL GUIDENCE SYSTEM |
05/12/2010 |
K000664 |
BAXTER HEALTHCARE CORP. |
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS |
09/20/2000 |
K132892 |
BOMED INC |
TEBCO-W |
08/01/2014 |
K122400 |
CARDIOX CORP. |
CARDIOX FLOW DETECTION SYSTEM |
11/05/2013 |
K101487 |
CHEETAH MEDICAL INC. |
CHEETAH NICOM SYSTEM |
07/02/2010 |
K042144 |
CHEETAH MEDICAL INC. |
NICOM |
11/12/2004 |
K071631 |
CHEETAH MEDICAL INC. |
NICOM ELECTRODES |
01/18/2008 |
K190955 |
Directed Systems Ltd |
Hypotension Decision Assist |
11/27/2019 |
K212529 |
Directed Systems Ltd |
Hypotension Decision Assist Model HDA-OR2 |
11/23/2021 |
K073113 |
Draeger Medical Systems, Inc. |
INFINITY PICCO POD, MODEL MS16734 |
01/03/2008 |
K110597 |
EDWARDS LIFESCIENCES |
EV1000 CLINICAL PLATFORM |
06/14/2011 |
K193179 |
Edwards Lifesciences, LLC |
EV1000 Clinical Platform |
12/17/2019 |
K131892 |
EDWARDS LIFESCIENCES, LLC. |
EV1000 CLINICAL PLATFORM |
05/22/2014 |
K100709 |
EDWARDS LIFESCIENCES, LLC. |
EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M |
12/07/2010 |
K060660 |
EDWARDS LIFESCIENCES, LLC. |
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER |
04/25/2006 |
K082308 |
EDWARDS LIFESCIENCES, LLC. |
MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
12/09/2008 |
K040287 |
EDWARDS LIFESCIENCES, LLC. |
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR |
04/26/2004 |
K043103 |
EDWARDS LIFESCIENCES, LLC. |
VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 |
12/09/2004 |
K103094 |
EDWARDS LIFESCIENCES, LLC. |
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR |
05/17/2011 |
K062134 |
EDWARDS LIFESCIENCES, LLC. |
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
08/22/2006 |
K131588 |
EDWARDS LIFESCIENCES, LLC. |
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR |
05/22/2014 |
K132528 |
GE HEALTHCARE FINLAND OY |
E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES |
01/16/2014 |
K962128 |
HEMO SAPIENS, INC. |
TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) |
11/21/1996 |
K152935 |
LIDCO LTD |
LiDCOunity Monitor |
03/17/2016 |
K163334 |
LiDCO Ltd |
LiDCOunity v2 Hemodynamic Monitor |
06/05/2017 |
K131048 |
LIDCO LTD. |
LIDCO CNAP MODULE |
08/28/2013 |
K962918 |
LIDCO LTD. |
LIDCO SYSTEM |
01/08/1999 |
K023960 |
LIDCO LTD. |
LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 |
01/09/2003 |
K122247 |
LIDCO LTD. |
LIDCORAPID V2 MONITOR |
03/20/2013 |
K010049 |
LIDCO LTD. |
PULSECO HEMODYNAMIC MONITOR CM71 |
06/14/2001 |
K032997 |
MENNEN MEDICAL LTD. |
MODIFICATION TO: HORIZON 9000WS |
10/15/2003 |
K991775 |
MENNEN MEDICAL, INC. |
MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS |
06/24/1999 |
K081776 |
OMEGA CRITICAL CARE LIMITED |
CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM |
07/22/2008 |
K060898 |
PULSION MEDICAL SYSTEMS AG |
PULSION PICCO PLUS, MODEL 8100 |
07/25/2006 |
K072735 |
PULSION MEDICAL SYSTEMS AG |
PULSION PICCO-2, MODEL 8500 |
10/18/2007 |
K091786 |
PULSION MEDICAL SYSTEMS AG |
PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48) |
06/18/2010 |
K172259 |
PULSION Medical Systems SE |
PulsioFlex Monitoring System |
01/18/2018 |
K122121 |
PULSION MEDICAL SYSTEMS SE |
PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE |
08/02/2012 |
K192169 |
Pulsion Medical Systems SE |
PulsioFlex Monitoring System with ProAQT Sensor |
04/30/2020 |
K112448 |
PULSION MEDICAL SYSTEMS, INC. |
PULSIOFLEX |
09/22/2011 |
K001762 |
PULSION MEDICAL SYSTEMS, INC. |
PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM |
06/13/2000 |
K181372 |
Retia Medical, LLC |
Argos |
12/13/2018 |
K113821 |
TRANSONIC SYSTEMS, INC. |
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM |
09/07/2012 |
K080116 |
TRANSONIC SYSTEMS, INC. |
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM |
09/08/2008 |
K134051 |
TRANSONIC SYSTEMS, INC. |
TRANSONIC ELSA SYSTEM |
01/29/2015 |
K140017 |
TRANSONIC SYSTEMS, INC. |
TRANSONIC HCM 102 SYSTEM |
09/16/2014 |
K134035 |
TRANSONIC SYSTEMS, INC. |
TRANSONIC HCM 103 SYSTEM |
09/17/2014 |
K955417 |
VITAL SIGNS, INC. |
VITAL PAK |
03/08/1996 |