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
K760756 3M HEALTH CARE, SARNS BATTERY OPERATED FLOW RATE COMPUTER 10/15/1976
K021874 ABBOTT LABORATORIES ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 07/12/2002
K771991 ABBOTT LABORATORIES CARDIAC OUTPUT THERMODILUTION MODULE 11/03/1977
K932414 ABBOTT LABORATORIES CONTINUOUS CARDIAC OUTPUT SYSTEM 11/14/1994
K961661 ABBOTT LABORATORIES OXIMETRIX 4 COMPUTER SYSTEM 03/04/1997
K812932 ABCO DEALERS, INC. ANERIOD GAUZE 12/02/1981
K897004 ADVANCED TECHNOLOGY LABORATORIES, INC. NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM 03/13/1990
K970784 ALEXANDER MFG. CO. ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T) 05/14/1997
K842105 AMERICAN EDWARDS LABORATORIES RIGHT VENTRICULAR EJECTION FRACTION- 01/15/1985
K841401 AMERICAN EDWARDS LABORATORIES SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER 01/14/1985
K872529 AMERICAN EDWARDS LABORATORIES THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 09/15/1987
K830892 AMERICAN EDWARDS LABORATORIES THERMODILUTION CARDIAC OUTPUT COMPUTER- 06/15/1983
K861505 AMERICAN MEDICAL EQUIPMENT, INC. HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER 04/10/1987
K831057 ANGIO TEC CORP. VIDEO-DILUTION TECH. MARK I INSTRUMENT 10/19/1983
K946115 APCOT MEDICAL SYSTEMS EK-VIEW(TM) ECG MANAGEMENT SYSTEM 03/01/1995
K092219 APPLIED PHYSIOLOGY PTY LTD. NAVIGATOR CLINICAL GUIDENCE SYSTEM 05/12/2010
K760844 B-D ELECTRODYNE CARDIAC OUTPUT COMPUTER (MODEL COC-100) 11/12/1976
K896930 BAXTER HEALTHCARE CORP. CARDIAC OUTPUT COMPUTER, MODEL COM-3 07/03/1990
K893392 BAXTER HEALTHCARE CORP. CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER 06/20/1989
K000664 BAXTER HEALTHCARE CORP. VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS 09/20/2000
K802198 BIOMETRIC ANALYSIS GROUP, INC. BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM 09/26/1980
K902628 BIOMETRIC RESEARCH INSTITUTE, INC. INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT 02/25/1991
K132892 BOMED INC TEBCO-W 08/01/2014
K813020 BOMED MEDICAL MFR., LTD. BOMED-NCCOM 12/14/1981
K772152 BURDICK CORP. CENTRAL MONITORING SYSTEM 11/28/1977
K844665 BURDICK CORP. COMPUTER 02/13/1985
K811062 CAMBRIDGE INSTRUMENTS, INC. CAMPBRIDGE COMPUTRACE 05/29/1981
K760600 CARDIOPULMONARY INSTRUMENTATION CARDIAC OUTPUT COMPUTER 10/15/1976
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
K852900 CHERNE INDUSTRIES, INC. CVERNE CAD DETECTOR 09/25/1985
K860015 CHERNE INDUSTRIES, INC. MODIFIED CHERNE CAD DETECTOR 04/23/1986
K861543 COLUMBUS INSTRUMENTS INTL. CORP. CARDIOMAX-II 03/10/1987
K771718 COLUMBUS INSTRUMENTS INTL. CORP. CARDIOTHERM-500X 09/28/1977
K820194 COMPU-CATH CORP. CARDIAC CATHERIZATION LAB MICROPROCESS 05/25/1982
K883855 CORAZONIX CORP. PREDICTOR II SIGNAL AVERAGING ECG 11/03/1988
K831967 CRITIKON COMPANY,LLC CRITIKON CARDIAC OUTPUT COMPUTER 10/28/1983
K844116 CRITIKON COMPANY,LLC CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC 05/28/1985
K770330 CYBORG CORP. MONITOR, PULSE WAVE VELOCITY P607 02/24/1977
K863308 DATASCOPE CORP. 2200I PHYSIOLOGICAL MONITOR 01/02/1987
K880301 DATASCOPE CORP. 3000 PHYSIOLOGICAL MONITOR 08/19/1988
K813222 DEL MAR AVIONICS MODEL 4200 ELLESTAD STRESS TEST ANALYZER 12/29/1981
K792080 DEL MAR AVIONICS MODEL 656 ARRHYTHMIA ANALYZER 12/04/1979
K863231 DEXTRA MEDICAL, INC. D100 COMPUTER CARDIAC ANALYSIS SYSTEM 11/25/1986
K863230 DEXTRA MEDICAL, INC. D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM 11/25/1986
K830628 DIAGNOSTIC ELECTRONICS CORP. REAL-TIME SPECTRUM ANALYZER 06/02/1983
K812638 DIAGNOSTIC RESOURCES, INC. DIAGNOSTIC MEDICAL COMPUTER 11/16/1981
K812515 DIASONICS, INC. CARDIAC REVIEW STATION 10/02/1981
K820820 DIASONICS, INC. CARDIO REVUE CENTER 04/29/1982
K073113 Draeger Medical Systems, Inc. INFINITY PICCO POD, MODEL MS16734 01/03/2008
K771924 DUNN INSTRUMENTS, INC. HEARTBEATER 11/28/1977
K862808 E.B.S., INC. BIOMA 2000 02/19/1987
K781535 EDWARDS LABORATORIES AC ADAPTER:MODELS 9525,9526,9527 09/15/1978
K790047 EDWARDS LABORATORIES CARDIAC OUTPUT COMPUTER, MDEL 9520A 02/26/1979
K760192 EDWARDS LABORATORIES COMPUTER, THERMODILUTION CARDIAC (9520) 07/19/1976
K110597 EDWARDS LIFESCIENCES EV1000 CLINICAL PLATFORM 06/14/2011
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
K811414 ELECTRO-CATHETER CORP. BAIM CORONARY SINUS FLOW ANALYZER 06/12/1981
K842831 ELECTRO-CATHETER CORP. BAIM CORONARY SINUS FLOW CALCULATOR 08/27/1984
K844682 ELECTRO-CATHETER CORP. ELECATH CARDIAC OUTPUT COMPUTER 03/06/1985
K844022 ELECTRO-CATHETER CORP. ELECATH VENTRICULAR PACING THERMAL DILUTION CATH 11/20/1984
K834059 FUKUDA DENSHI USA, INC. FUKUDA DENSHI EH-11 06/21/1985
K132528 GE HEALTHCARE FINLAND OY E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES 01/16/2014
K770179 GENERAL ELECTRIC CO. CARDIAC CATHETERIZATION LAB MONITOR SYS 04/05/1977
K802316 GENERAL ELECTRIC CO. PDS THERMAL DILUTION CARDIAC MODULE(OUT) 11/26/1980
K843555 GOULD, INC. CARDIAC COMPUTER SP1445 02/01/1985
K802476 GOULD, INC. CARDIACINDEX COMPUTER MODEL SP 1435 11/19/1980
K760532 GOULD, INC. COMPUTER, CARDIAC OUTPUT (#SP1425) 09/09/1976
K861092 GOULD, INC. MODEL SP1465 CARDIAC OUTPUT COMPUTER 08/18/1986
K962128 HEMO SAPIENS, INC. TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) 11/21/1996
K833914 HEWLETT-PACKARD CO. CARDIAC OUTPUT SIGNAL ACQUISTION 03/22/1984
K833913 HEWLETT-PACKARD CO. HEMODYNAMIC PLUG-IN MODULE 78551A 03/22/1984
K850568 HEWLETT-PACKARD CO. MODEL 78231D CARDIAC OUTPUT MODULE 04/09/1985
K822877 HEWLETT-PACKARD CO. MODEL 78554A DATA MGMT. PLUG-IN MODULE 10/18/1982
K841256 HEWLETT-PACKARD CO. MODELS 78551A 78552A 10/02/1984
K760774 HEWLETT-PACKARD CO. TIME-SHARING MULTIPLEXER (MODEL 78308A) 10/13/1976
K810163 HONEYWELL, INC. AM 420 MICROPROCESSOR 03/05/1981
K781855 HONEYWELL, INC. LVV OPTION 01/05/1979
K810177 HONEYWELL, INC. PATIENT MONITOR MODEL CM130, 140 02/25/1981
K810170 HONEYWELL, INC. TREND GRAPH FUNCTION BLOCK 02/25/1981
K822972 INSTRUMENTATION LABORATORY CO. IL 801 THERMALDILUTION CARDIAC OUTPUT 11/01/1982
K870934 INTEGRATED MEDICAL SYSTEMS, INC. IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM 05/06/1987
K871659 INTEGRATED MEDICAL SYSTEMS, INC. IMS-2000S STRESS MONITOR 05/28/1987
K844997 INTL. ACOUSTICS, INC. IAI PROGRAM-COMPUTER PROGRAM 04/09/1985
K862261 KONTRON INSTRUMENTS, INC. KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263 02/19/1987
K770675 LEXINGTON INSTRUMENTS COMPUTER, CARDIAC OUTPUT, MODEL KM275 04/26/1977
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
K811560 LIFE SCIENCES MANUFACTURING, INC. AUTOMATED PHYSIOLOGIC PROFILE MONITOR 06/18/1981
K896528 LIFE SCIENCES MANUFACTURING, INC. SFA MODULE 01/26/1990
K791756 LIFE SCIENCES MANUFACTURING, INC. VDC 11/27/1979
K840439 LITTON MEDICAL ELECTRONICS RECOMED CARDIAC OUTPUT METER 236067- 11/20/1984
K854136 MARQUETTE ELECTRONICS, INC. ARRHYTHMIA REVIEW STATION 12/04/1985
K820898 MEDASONICS, INC. VASCULAB SPECTRUM ANALYZER #SP25 04/21/1982
K880696 MEDEX, INC. MX1002 CABLE-CAL TM 06/15/1988
K943256 MEDICAL DATA ELECTRONICS CARDIAC OUTPUT OPTION 39 12/15/1994
K833756 MEDICAL GRAPHICS CORP. SYSTEM 5000 04/24/1984
K032997 MENNEN MEDICAL LTD. MODIFICATION TO: HORIZON 9000WS 10/15/2003
K875167 MENNEN MEDICAL, INC. HORIZON 9000 05/31/1988
K940415 MENNEN MEDICAL, INC. HORIZON 9000 WS 01/06/1995
K991775 MENNEN MEDICAL, INC. MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS 06/24/1999
K830003 MICROFIT, INC. MICRO FITNESS COMPUTER 03/10/1983
K802800 NARCO AIR-SHIELDS NARCO AIR-SHEILDS SYS. 100 MONITOR SYS 11/24/1980
K841261 NEM COMPUTER CORP. COMPUTER, CENTRAL PROCESSING UNIT 08/10/1984
K792678 NIHON KOHDEN AMERICA, INC. CARDIAC OUTPUT COMPUTER, M-MLC-4100 01/09/1980
K802305 NIHON KOHDEN AMERICA, INC. MLC-4200 CARDIAC OUTPUT COMPUTER 10/10/1980
K854371 NIHON KOHDEN AMERICA, INC. MTC 6210A CARDIAC OUTPUT COMPUTER 02/19/1987
K840009 NOVA MEDICAL SPECIALTIES NOVA 12 CARDIAC OUTPUT COMPUTER 08/22/1984
K812971 OCG TECHNOLOGY, INC. CARDIOINTEGRAM 12/29/1981
K863153 OCG TECHNOLOGY, INC. MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH 01/06/1987
K884619 OCULAB, INC. PACH-PEN CALCULATOR 02/02/1989
K081776 OMEGA CRITICAL CARE LIMITED CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM 07/22/2008
K844277 OMIKRON SCIENTIFIC, LTD. OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR 02/15/1985
K870375 OMNIMED B.V. MODEL 617 CARDIAC OUTPUT COMPUTER 06/16/1987
K822903 OXFORD MEDILOG, INC. AUTOECHO 11/01/1982
K790288 OXFORD MEDILOG, INC. STORAGE, DIGITAL DSC-1, CONTROL UNIT 02/27/1979
K853018 OXIMETRIX, INC. MODEL 3000 OPTICATH COMPUTER 01/13/1986
K841967 PARKE-DAVIS CO. DESERET THERMODILUTION CARDIAC OUTPUT 08/19/1985
K913358 PPG INDUSTRIES, INC. MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST 12/20/1991
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
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
K861437 QMED, INC. QMED SYSTEM 2150 05/20/1986
K833395 QUANTITATIVE MEDICINE, INC. SENTINEL SYSTEMS 01/10/1984
K810851 RADIONICS MEDICAL, INC. SPECTRUM ANALYZER 8000 04/23/1981
K922218 RENAISSANCE TECHNOLOGY, INC. IQ SYSTEM 12/08/1992
K791753 ROBINTON CORP. IPAG MICRONOVA INTERFACE #781111 10/02/1979
K884122 S & W MEDICO TEKNIK TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA 04/25/1989
K813223 SAM JOO INDUSTRIAL CO., LTD. DISPOSABLE PLASTIC SYRINGE W/NEEDLE 04/15/1982
K842706 SC APPLIED TECHNOLOGY, INC. SCATAID 11/27/1984
K771666 SEARS, ROEBUCK & CO. SPHYGMOMANOMETER #1235 09/30/1977
K894234 SENSOCOR SENSOCOR TM R-TEST 24OXL 08/03/1989
K901926 SORBA MEDICAL SYSTEMS, INC. SORBA MODEL CIC-1000 W/NEW ELECTRODES 06/12/1990
K895017 SORBA MEDICAL SYSTEMS, INC. SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH 03/14/1990
K812757 SORENSEN RESEARCH SORENSON THERMODILUTION CARDIAC COMPUT 11/02/1981
K832644 SPACELABS, INC. ALPHA CARDIAC OUTPUT CARDULE #1899 01/27/1984
K865101 SPECTRAMED, INC. SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM 04/20/1987
K822093 SURVIVAL TECHNOLOGY, INC. STAT-SCAN 09/21/1982
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
K772158 VARIAN ASSOC., INC. LIGHT-PEN SYSTEM FOR QUANTI. ANALY. 11/22/1977
K955417 VITAL SIGNS, INC. VITAL PAK 03/08/1996
K781805 WATERS ASSOC., INC. CARDIAC COMPUTERS, CO-10 & CO-10R 01/29/1979
K761166 WATERS ASSOC., INC. TC-1 CARDIAC OUTPUT COMPUTER 12/09/1976
K834408 WATERS INSTRUMENTS, INC. TX-2 THERMAL DILUTION CARDIAC OUTPUT 08/23/1984
K880258 WITT BIOMEDICAL CORPORATION WITT BIOMEDICAL VX-80 06/16/1988
K831407 ZIEHM INTERNATIONAL, INC. CARDIAC OUTPUT COMPUTER 10/14/1983


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