FDA 510(k) Applications for Medical Device Product Code "DXG"
(Computer, Diagnostic, Pre-Programmed, Single-Function)
| 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 |
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