Product Code: DXG FDA class 2 21 CFR 870.1435

Computer, Diagnostic, Pre-Programmed, Single-Function

Cardiovascular

The Pre-Programmed Single-Function Diagnostic Computer is a cardiovascular computing device designed to perform a specific diagnostic calculation or analysis function, such as computing cardiac output or vascular resistance, based on pre-set algorithms applied to physiological input signals. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DXG and it is regulated under 21 CFR 870.1435 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

177

FEI Numbers

Registration Numbers

Unique Applicants

106

Years Active

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Basic Information

Product Code: DXG
Device Class: FDA class 2
Regulation Number: 870.1435
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 177 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253092	Argos Infinity (Rev. 1.0)	Feb 13, 2026	Substantially Equivalent	Retia Medical Systems, Inc.
K251275	VitalStream ART Connect; VitalStream-Hemo	Sep 26, 2025	Substantially Equivalent	Caretaker Medical
K232048	Cogent Hemodynamic Monitoring System; Cogent HMS	Dec 20, 2023	Substantially Equivalent	Icu Medical
K212529	Hypotension Decision Assist Model HDA-OR2	Nov 23, 2021	Substantially Equivalent	Directed Systems, Ltd.
K192169	PulsioFlex Monitoring System with ProAQT Sensor	Apr 30, 2020	Substantially Equivalent	Pulsion Medical Systems SE
K193179	EV1000 Clinical Platform	Dec 17, 2019	Substantially Equivalent	Edwards Lifesciences, LLC
K190955	Hypotension Decision Assist	Nov 27, 2019	Substantially Equivalent	Directed Systems, Ltd.
K181372	Argos	Dec 13, 2018	Substantially Equivalent	Retia Medical, LLC
K172259	PulsioFlex Monitoring System	Jan 18, 2018	Substantially Equivalent	Pulsion Medical Systems SE
K163334	LiDCOunity v2 Hemodynamic Monitor	Jun 05, 2017	Substantially Equivalent	Lidco, Ltd.
K152935	LiDCOunity Monitor	Mar 17, 2016	Substantially Equivalent	Lidco, Ltd.
K134051	TRANSONIC ELSA SYSTEM	Jan 29, 2015	Substantially Equivalent	Transonic Systems, Inc.
K134035	TRANSONIC HCM 103 SYSTEM	Sep 17, 2014	Substantially Equivalent	Transonic Systems, Inc.
K140017	TRANSONIC HCM 102 SYSTEM	Sep 16, 2014	Substantially Equivalent	Transonic Systems, Inc.
K132892	TEBCO-W	Aug 01, 2014	Substantially Equivalent	Bomed, Inc.
K131892	EV1000 CLINICAL PLATFORM	May 22, 2014	Substantially Equivalent	Edwards Lifesciences, LLC
K131588	VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR	May 22, 2014	Substantially Equivalent	Edwards Lifesciences, LLC
K132528	E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES	Jan 16, 2014	Substantially Equivalent	GE Healthcare Finland Oy
K122400	CARDIOX FLOW DETECTION SYSTEM	Nov 05, 2013	Substantially Equivalent	Cardiox Corp.
K131048	LIDCO CNAP MODULE	Aug 28, 2013	Substantially Equivalent	Lidco, Ltd.
K122247	LIDCORAPID V2 MONITOR	Mar 20, 2013	Substantially Equivalent	Lidco, Ltd.
K113821	TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM	Sep 07, 2012	Substantially Equivalent	Transonic Systems, Inc.
K122121	PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE	Aug 02, 2012	Substantially Equivalent	Pulsion Medical Systems SE
K112448	PULSIOFLEX	Sep 22, 2011	Substantially Equivalent	Pulsion Medical Systems, Inc.
K110597	EV1000 CLINICAL PLATFORM	Jun 14, 2011	Substantially Equivalent	Edwards Lifesciences
K103094	VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR	May 17, 2011	Substantially Equivalent	Edwards Lifesciences, LLC
K100709	EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M	Dec 07, 2010	Substantially Equivalent	Edwards Lifesciences, LLC
K101487	CHEETAH NICOM SYSTEM	Jul 02, 2010	Substantially Equivalent	Cheetah Medical, Inc.
K091786	PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)	Jun 18, 2010	Substantially Equivalent	Pulsion Medical Systems AG
K092219	NAVIGATOR CLINICAL GUIDENCE SYSTEM	May 12, 2010	Substantially Equivalent	Applied Physiology Pty , Ltd.
K082308	MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR	Dec 09, 2008	Substantially Equivalent	Edwards Lifesciences, LLC
K080116	TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM	Sep 08, 2008	Substantially Equivalent	Transonic Systems, Inc.
K081776	CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM	Jul 22, 2008	Substantially Equivalent	Omega Critical Care Limited
K071631	NICOM ELECTRODES	Jan 18, 2008	Substantially Equivalent	Cheetah Medical, Inc.
K073113	INFINITY PICCO POD, MODEL MS16734	Jan 03, 2008	Substantially Equivalent	Draeger Medical Systems, Inc.
K072735	PULSION PICCO-2, MODEL 8500	Oct 18, 2007	Substantially Equivalent	Pulsion Medical Systems AG
K062134	VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR	Aug 22, 2006	Substantially Equivalent	Edwards Lifesciences, LLC
K060898	PULSION PICCO PLUS, MODEL 8100	Jul 25, 2006	Substantially Equivalent	Pulsion Medical Systems AG
K060660	EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER	Apr 25, 2006	Substantially Equivalent	Edwards Lifesciences, LLC
K043103	VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2	Dec 09, 2004	Substantially Equivalent	Edwards Lifesciences, LLC
K042144	NICOM	Nov 12, 2004	Substantially Equivalent	Cheetah Medical, Inc.
K040287	VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR	Apr 26, 2004	Substantially Equivalent	Edwards Lifesciences, LLC
K032997	MODIFICATION TO: HORIZON 9000WS	Oct 15, 2003	Substantially Equivalent	Mennen Medical , Ltd.
K023960	LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70	Jan 09, 2003	Substantially Equivalent	Lidco, Ltd.
K021874	ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711	Jul 12, 2002	Substantially Equivalent	Abbott Laboratories
K010049	PULSECO HEMODYNAMIC MONITOR CM71	Jun 14, 2001	Substantially Equivalent	Lidco, Ltd.
K000664	VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS	Sep 20, 2000	Substantially Equivalent	Baxter Healthcare Corp
K001762	PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM	Jun 13, 2000	Substantially Equivalent	Pulsion Medical Systems, Inc.
K991775	MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS	Jun 24, 1999	Substantially Equivalent	Mennen Medical, Inc.
K962918	LIDCO SYSTEM	Jan 08, 1999	Substantially Equivalent	Lidco, Ltd.
K970784	ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)	May 14, 1997	Substantially Equivalent	Alexander Mfg. Co.
K961661	OXIMETRIX 4 COMPUTER SYSTEM	Mar 04, 1997	Substantially Equivalent	Abbott Laboratories
K962128	TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)	Nov 21, 1996	Substantially Equivalent	Hemo Sapiens, Inc.
K955417	VITAL PAK	Mar 08, 1996	Unknown	Vital Signs, Inc.
K946115	EK-VIEW(TM) ECG MANAGEMENT SYSTEM	Mar 01, 1995	Substantially Equivalent	Apcot Medical Systems
K940415	HORIZON 9000 WS	Jan 06, 1995	Substantially Equivalent	Mennen Medical, Inc.
K943256	CARDIAC OUTPUT OPTION 39	Dec 15, 1994	Substantially Equivalent	Medical Data Electronics
K932414	CONTINUOUS CARDIAC OUTPUT SYSTEM	Nov 14, 1994	Substantially Equivalent	Abbott Laboratories
K922218	IQ SYSTEM	Dec 08, 1992	Substantially Equivalent	Renaissance Technology, Inc.
K913358	MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST	Dec 20, 1991	Substantially Equivalent	Ppg Industries, Inc.
K902628	INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT	Feb 25, 1991	Substantially Equivalent	Biometric Research Institute, Inc.
K896930	CARDIAC OUTPUT COMPUTER, MODEL COM-3	Jul 03, 1990	Substantially Equivalent	Baxter Healthcare Corp
K901926	SORBA MODEL CIC-1000 W/NEW ELECTRODES	Jun 12, 1990	Substantially Equivalent	Sorba Medical Systems, Inc.
K895017	SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH	Mar 14, 1990	Substantially Equivalent	Sorba Medical Systems, Inc.
K897004	NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM	Mar 13, 1990	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K896528	SFA MODULE	Jan 26, 1990	Substantially Equivalent	Life Sciences Manufacturing, Inc.
K894234	SENSOCOR TM R-TEST 24OXL	Aug 03, 1989	Substantially Equivalent	Sensocor
K893392	CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER	Jun 20, 1989	Substantially Equivalent	Baxter Healthcare Corp
K884122	TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA	Apr 25, 1989	Substantially Equivalent	S & W Medico Teknik
K884619	PACH-PEN CALCULATOR	Feb 02, 1989	Substantially Equivalent	Oculab, Inc.
K883855	PREDICTOR II SIGNAL AVERAGING ECG	Nov 03, 1988	Substantially Equivalent	Corazonix Corp.
K880301	3000 PHYSIOLOGICAL MONITOR	Aug 19, 1988	Substantially Equivalent	Datascope Corp.
K880258	WITT BIOMEDICAL VX-80	Jun 16, 1988	Substantially Equivalent	Witt Biomedical Corporation
K880696	MX1002 CABLE-CAL TM	Jun 15, 1988	Substantially Equivalent	Medex, Inc.
K875167	HORIZON 9000	May 31, 1988	Substantially Equivalent	Mennen Medical, Inc.
K872529	THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2	Sep 15, 1987	Substantially Equivalent	American Edwards Laboratories
K870375	MODEL 617 CARDIAC OUTPUT COMPUTER	Jun 16, 1987	Substantially Equivalent	Omnimed B.V.
K871659	IMS-2000S STRESS MONITOR	May 28, 1987	Substantially Equivalent	Integrated Medical Systems, Inc.
K870934	IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM	May 06, 1987	Substantially Equivalent	Integrated Medical Systems, Inc.
K865101	SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM	Apr 20, 1987	Substantially Equivalent	Spectramed, Inc.
K861505	HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER	Apr 10, 1987	Substantially Equivalent	American Medical Equipment, Inc.
K861543	CARDIOMAX-II	Mar 10, 1987	Substantially Equivalent	Columbus Instruments Intl. Corp.
K862808	BIOMA 2000	Feb 19, 1987	Substantially Equivalent	E.B.S., Inc.
K862261	KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263	Feb 19, 1987	Substantially Equivalent	Kontron Instruments, Inc.
K854371	MTC 6210A CARDIAC OUTPUT COMPUTER	Feb 19, 1987	Substantially Equivalent	Nihon Kohden America, Inc.
K863153	MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH	Jan 06, 1987	Substantially Equivalent	Ocg Technology, Inc.
K863308	2200I PHYSIOLOGICAL MONITOR	Jan 02, 1987	Substantially Equivalent	Datascope Corp.
K863231	D100 COMPUTER CARDIAC ANALYSIS SYSTEM	Nov 25, 1986	Substantially Equivalent	Dextra Medical, Inc.
K863230	D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM	Nov 25, 1986	Substantially Equivalent	Dextra Medical, Inc.
K861092	MODEL SP1465 CARDIAC OUTPUT COMPUTER	Aug 18, 1986	Substantially Equivalent	Gould, Inc.
K861437	QMED SYSTEM 2150	May 20, 1986	Substantially Equivalent	Qmed, Inc.
K860015	MODIFIED CHERNE CAD DETECTOR	Apr 23, 1986	Substantially Equivalent	Cherne Industries, Inc.
K853018	MODEL 3000 OPTICATH COMPUTER	Jan 13, 1986	Substantially Equivalent	Oximetrix, Inc.
K854136	ARRHYTHMIA REVIEW STATION	Dec 04, 1985	Substantially Equivalent	Marquette Electronics, Inc.
K852900	CVERNE CAD DETECTOR	Sep 25, 1985	Substantially Equivalent	Cherne Industries, Inc.
K841967	DESERET THERMODILUTION CARDIAC OUTPUT	Aug 19, 1985	Substantially Equivalent	Parke-Davis Co.
K834059	FUKUDA DENSHI EH-11	Jun 21, 1985	Substantially Equivalent	Fukuda Denshi USA, Inc.
K844116	CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC	May 28, 1985	Substantially Equivalent	Critikon Company, LLC
K850568	MODEL 78231D CARDIAC OUTPUT MODULE	Apr 09, 1985	Substantially Equivalent	Hewlett-Packard Co.
K844997	IAI PROGRAM-COMPUTER PROGRAM	Apr 09, 1985	Substantially Equivalent	Intl. Acoustics, Inc.
K844682	ELECATH CARDIAC OUTPUT COMPUTER	Mar 06, 1985	Substantially Equivalent	Electro-Catheter Corp.
K844277	OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR	Feb 15, 1985	Substantially Equivalent	Omikron Scientific, Ltd.
K844665	COMPUTER	Feb 13, 1985	Substantially Equivalent	Burdick Corp.
K843555	CARDIAC COMPUTER SP1445	Feb 01, 1985	Substantially Equivalent	Gould, Inc.
K842105	RIGHT VENTRICULAR EJECTION FRACTION-	Jan 15, 1985	Substantially Equivalent	American Edwards Laboratories
K841401	SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER	Jan 14, 1985	Substantially Equivalent	American Edwards Laboratories
K842706	SCATAID	Nov 27, 1984	Substantially Equivalent	Sc Applied Technology, Inc.
K844022	ELECATH VENTRICULAR PACING THERMAL DILUTION CATH	Nov 20, 1984	Substantially Equivalent	Electro-Catheter Corp.
K840439	RECOMED CARDIAC OUTPUT METER 236067-	Nov 20, 1984	Substantially Equivalent	Litton Medical Electronics
K841256	MODELS 78551A 78552A	Oct 02, 1984	Substantially Equivalent	Hewlett-Packard Co.
K842831	BAIM CORONARY SINUS FLOW CALCULATOR	Aug 27, 1984	Substantially Equivalent	Electro-Catheter Corp.
K834408	TX-2 THERMAL DILUTION CARDIAC OUTPUT	Aug 23, 1984	Substantially Equivalent	Waters Instruments, Inc.
K840009	NOVA 12 CARDIAC OUTPUT COMPUTER	Aug 22, 1984	Substantially Equivalent	Nova Medical Specialties
K841261	COMPUTER, CENTRAL PROCESSING UNIT	Aug 10, 1984	Substantially Equivalent	Nem Computer Corp.
K833756	SYSTEM 5000	Apr 24, 1984	Substantially Equivalent	Medical Graphics Corp.
K833914	CARDIAC OUTPUT SIGNAL ACQUISTION	Mar 22, 1984	Substantially Equivalent	Hewlett-Packard Co.
K833913	HEMODYNAMIC PLUG-IN MODULE 78551A	Mar 22, 1984	Substantially Equivalent	Hewlett-Packard Co.
K832644	ALPHA CARDIAC OUTPUT CARDULE #1899	Jan 27, 1984	Substantially Equivalent	Spacelabs, Inc.
K833395	SENTINEL SYSTEMS	Jan 10, 1984	Substantially Equivalent	Quantitative Medicine, Inc.
K831967	CRITIKON CARDIAC OUTPUT COMPUTER	Oct 28, 1983	Substantially Equivalent	Critikon Company, LLC
K831057	VIDEO-DILUTION TECH. MARK I INSTRUMENT	Oct 19, 1983	Substantially Equivalent	Angio Tec Corp.
K831407	CARDIAC OUTPUT COMPUTER	Oct 14, 1983	Substantially Equivalent	Ziehm International, Inc.
K830892	THERMODILUTION CARDIAC OUTPUT COMPUTER-	Jun 15, 1983	Substantially Equivalent	American Edwards Laboratories
K830628	REAL-TIME SPECTRUM ANALYZER	Jun 02, 1983	Substantially Equivalent	Diagnostic Electronics Corp.
K830003	MICRO FITNESS COMPUTER	Mar 10, 1983	Substantially Equivalent	Microfit, Inc.
K822972	IL 801 THERMALDILUTION CARDIAC OUTPUT	Nov 01, 1982	Substantially Equivalent	Instrumentation Laboratory CO
K822903	AUTOECHO	Nov 01, 1982	Substantially Equivalent	Oxford Medilog, Inc.
K822877	MODEL 78554A DATA MGMT. PLUG-IN MODULE	Oct 18, 1982	Substantially Equivalent	Hewlett-Packard Co.
K822093	STAT-SCAN	Sep 21, 1982	Substantially Equivalent	Survival Technology, Inc.
K820194	CARDIAC CATHERIZATION LAB MICROPROCESS	May 25, 1982	Substantially Equivalent	Compu-Cath Corp.
K820820	CARDIO REVUE CENTER	Apr 29, 1982	Substantially Equivalent	Diasonics, Inc.
K820898	VASCULAB SPECTRUM ANALYZER #SP25	Apr 21, 1982	Substantially Equivalent	Medasonics, Inc.
K813223	DISPOSABLE PLASTIC SYRINGE W/NEEDLE	Apr 15, 1982	Substantially Equivalent	Sam Joo Industrial Co., Ltd.
K813222	MODEL 4200 ELLESTAD STRESS TEST ANALYZER	Dec 29, 1981	Substantially Equivalent	Del Mar Avionics
K812971	CARDIOINTEGRAM	Dec 29, 1981	Substantially Equivalent	Ocg Technology, Inc.
K813020	BOMED-NCCOM	Dec 14, 1981	Substantially Equivalent	Bomed Medical Mfr., Ltd.
K812932	ANERIOD GAUZE	Dec 02, 1981	Substantially Equivalent	Abco Dealers, Inc.
K812638	DIAGNOSTIC MEDICAL COMPUTER	Nov 16, 1981	Substantially Equivalent	Diagnostic Resources, Inc.
K812757	SORENSON THERMODILUTION CARDIAC COMPUT	Nov 02, 1981	Substantially Equivalent	Sorensen Research
K812515	CARDIAC REVIEW STATION	Oct 02, 1981	Substantially Equivalent	Diasonics, Inc.
K811560	AUTOMATED PHYSIOLOGIC PROFILE MONITOR	Jun 18, 1981	Substantially Equivalent	Life Sciences Manufacturing, Inc.
K811414	BAIM CORONARY SINUS FLOW ANALYZER	Jun 12, 1981	Substantially Equivalent	Electro-Catheter Corp.
K811062	CAMPBRIDGE COMPUTRACE	May 29, 1981	Substantially Equivalent	Cambridge Instruments, Inc.
K810851	SPECTRUM ANALYZER 8000	Apr 23, 1981	Substantially Equivalent	Radionics Medical, Inc.
K810163	AM 420 MICROPROCESSOR	Mar 05, 1981	Substantially Equivalent	Honeywell, Inc.
K810177	PATIENT MONITOR MODEL CM130, 140	Feb 25, 1981	Substantially Equivalent	Honeywell, Inc.
K810170	TREND GRAPH FUNCTION BLOCK	Feb 25, 1981	Substantially Equivalent	Honeywell, Inc.
K802316	PDS THERMAL DILUTION CARDIAC MODULE(OUT)	Nov 26, 1980	Substantially Equivalent	General Electric Co.
K802800	NARCO AIR-SHEILDS SYS. 100 MONITOR SYS	Nov 24, 1980	Substantially Equivalent	Narco Air-Shields
K802476	CARDIACINDEX COMPUTER MODEL SP 1435	Nov 19, 1980	Substantially Equivalent	Gould, Inc.
K802305	MLC-4200 CARDIAC OUTPUT COMPUTER	Oct 10, 1980	Substantially Equivalent	Nihon Kohden America, Inc.
K802198	BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM	Sep 26, 1980	Substantially Equivalent	Biometric Analysis Group, Inc.
K792678	CARDIAC OUTPUT COMPUTER, M-MLC-4100	Jan 09, 1980	Substantially Equivalent	Nihon Kohden America, Inc.
K792080	MODEL 656 ARRHYTHMIA ANALYZER	Dec 04, 1979	Substantially Equivalent	Del Mar Avionics
K791756	VDC	Nov 27, 1979	Substantially Equivalent	Life Sciences Manufacturing, Inc.
K791753	IPAG MICRONOVA INTERFACE #781111	Oct 02, 1979	Substantially Equivalent	Robinton Corp.
K790288	STORAGE, DIGITAL DSC-1, CONTROL UNIT	Feb 27, 1979	Substantially Equivalent	Oxford Medilog, Inc.
K790047	CARDIAC OUTPUT COMPUTER, MDEL 9520A	Feb 26, 1979	Substantially Equivalent	Edwards Laboratories
K781805	CARDIAC COMPUTERS, CO-10 & CO-10R	Jan 29, 1979	Substantially Equivalent	Waters Assoc., Inc.
K781855	LVV OPTION	Jan 05, 1979	Substantially Equivalent	Honeywell, Inc.
K781535	AC ADAPTER:MODELS 9525,9526,9527	Sep 15, 1978	Substantially Equivalent	Edwards Laboratories
K772152	CENTRAL MONITORING SYSTEM	Nov 28, 1977	Substantially Equivalent	Burdick Corp.
K771924	HEARTBEATER	Nov 28, 1977	Substantially Equivalent	Dunn Instruments, Inc.
K772158	LIGHT-PEN SYSTEM FOR QUANTI. ANALY.	Nov 22, 1977	Substantially Equivalent	Varian Assoc., Inc.
K771991	CARDIAC OUTPUT THERMODILUTION MODULE	Nov 03, 1977	Substantially Equivalent	Abbott Laboratories
K771666	SPHYGMOMANOMETER #1235	Sep 30, 1977	Substantially Equivalent	Sears, Roebuck & Co.
K771718	CARDIOTHERM-500X	Sep 28, 1977	Substantially Equivalent	Columbus Instruments Intl. Corp.
K770675	COMPUTER, CARDIAC OUTPUT, MODEL KM275	Apr 26, 1977	Substantially Equivalent	Lexington Instruments
K770179	CARDIAC CATHETERIZATION LAB MONITOR SYS	Apr 05, 1977	Substantially Equivalent	General Electric Co.
K770330	MONITOR, PULSE WAVE VELOCITY P607	Feb 24, 1977	Substantially Equivalent	Cyborg Corp.
K761166	TC-1 CARDIAC OUTPUT COMPUTER	Dec 09, 1976	Substantially Equivalent	Waters Assoc., Inc.
K760844	CARDIAC OUTPUT COMPUTER (MODEL COC-100)	Nov 12, 1976	Substantially Equivalent	B-D Electrodyne
K760756	BATTERY OPERATED FLOW RATE COMPUTER	Oct 15, 1976	Substantially Equivalent	3M Health Care, Sarns
K760600	CARDIAC OUTPUT COMPUTER	Oct 15, 1976	Substantially Equivalent	Cardiopulmonary Instrumentation
K760774	TIME-SHARING MULTIPLEXER (MODEL 78308A)	Oct 13, 1976	Substantially Equivalent	Hewlett-Packard Co.
K760532	COMPUTER, CARDIAC OUTPUT (#SP1425)	Sep 09, 1976	Substantially Equivalent	Gould, Inc.
K760192	COMPUTER, THERMODILUTION CARDIAC (9520)	Jul 19, 1976	Substantially Equivalent	Edwards Laboratories