ClearanceBrief
Panels › Cardiovascular › Product code DXG · Class 2

Computer, Diagnostic, Pre-Programmed, Single-Function

Regulation 870.1435

1510(k)s in 12 months (177 all time)
0recalls in 12 months (14 all time)
14recalls that name a 510(k)
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Top companies in DXG

Decided510(k)Device and applicantCode
May 14, 1997K970784ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)
Alexander Mfg. Co.
DXG
Mar 4, 1997K961661OXIMETRIX 4 COMPUTER SYSTEM
Abbott Laboratories
DXG
Nov 21, 1996K962128TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)
Hemo Sapiens, Inc.
DXG
Mar 8, 1996K955417VITAL PAK
Vital Signs, Inc.
DXG
Mar 1, 1995K946115EK-VIEW(TM) ECG MANAGEMENT SYSTEM
Apcot Medical Systems
DXG
Jan 6, 1995K940415HORIZON 9000 WS
Mennen Medical, Inc.
DXG
Dec 15, 1994K943256CARDIAC OUTPUT OPTION 39
Medical Data Electronics
DXG
Nov 14, 1994K932414CONTINUOUS CARDIAC OUTPUT SYSTEM
Abbott Laboratories
DXG
Dec 8, 1992K922218IQ SYSTEM
Renaissance Technology, Inc.
DXG
Dec 20, 1991K913358MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST
Ppg Industries, Inc.
DXG
Feb 25, 1991K902628INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT
Biometric Research Institute, Inc.
DXG
Jul 3, 1990K896930CARDIAC OUTPUT COMPUTER, MODEL COM-3
Baxter Healthcare Corp
DXG
Jun 12, 1990K901926SORBA MODEL CIC-1000 W/NEW ELECTRODES
Sorba Medical Systems, Inc.
DXG
Mar 14, 1990K895017SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH
Sorba Medical Systems, Inc.
DXG
Mar 13, 1990K897004NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM
Advanced Technology Laboratories, Inc.
DXG
Jan 26, 1990K896528SFA MODULE
Life Sciences Manufacturing, Inc.
DXG
Aug 3, 1989K894234SENSOCOR TM R-TEST 24OXL
Sensocor
DXG
Jun 20, 1989K893392CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
Baxter Healthcare Corp
DXG
Apr 25, 1989K884122TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA
S & W Medico Teknik, DK
DXG
Feb 2, 1989K884619PACH-PEN CALCULATOR
Oculab, Inc.
DXG
Nov 3, 1988K883855PREDICTOR II SIGNAL AVERAGING ECG
Corazonix Corp.
DXG
Aug 19, 1988K8803013000 PHYSIOLOGICAL MONITOR
Datascope Corp.
DXG
Jun 16, 1988K880258WITT BIOMEDICAL VX-80
Witt Biomedical Corporation
DXG
Jun 15, 1988K880696MX1002 CABLE-CAL TM
Medex, Inc.
DXG
May 31, 1988K875167HORIZON 9000
Mennen Medical, Inc.
DXG
Sep 15, 1987K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
American Edwards Laboratories
DXG
Jun 16, 1987K870375MODEL 617 CARDIAC OUTPUT COMPUTER
Omnimed B.V., NL
DXG
May 28, 1987K871659IMS-2000S STRESS MONITOR
Integrated Medical Systems, Inc.
DXG
May 6, 1987K870934IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM
Integrated Medical Systems, Inc.
DXG
Apr 20, 1987K865101SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM
Spectramed, Inc.
DXG
Apr 10, 1987K861505HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER
American Medical Equipment, Inc.
DXG
Mar 10, 1987K861543CARDIOMAX-II
Columbus Instruments Intl. Corp.
DXG
Feb 19, 1987K862808BIOMA 2000
E.B.S., Inc., CA
DXG
Feb 19, 1987K862261KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263
Kontron Instruments, Inc.
DXG
Feb 19, 1987K854371MTC 6210A CARDIAC OUTPUT COMPUTER
Nihon Kohden America, Inc.
DXG
Jan 6, 1987K863153MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH
Ocg Technology, Inc.
DXG
Jan 2, 1987K8633082200I PHYSIOLOGICAL MONITOR
Datascope Corp.
DXG
Nov 25, 1986K863231D100 COMPUTER CARDIAC ANALYSIS SYSTEM
Dextra Medical, Inc.
DXG
Nov 25, 1986K863230D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM
Dextra Medical, Inc.
DXG
Aug 18, 1986K861092MODEL SP1465 CARDIAC OUTPUT COMPUTER
Gould, Inc.
DXG
May 20, 1986K861437QMED SYSTEM 2150
Qmed, Inc.
DXG
Apr 23, 1986K860015MODIFIED CHERNE CAD DETECTOR
Cherne Industries, Inc.
DXG
Jan 13, 1986K853018MODEL 3000 OPTICATH COMPUTER
Oximetrix, Inc.
DXG
Dec 4, 1985K854136ARRHYTHMIA REVIEW STATION
Marquette Electronics, Inc.
DXG
Sep 25, 1985K852900CVERNE CAD DETECTOR
Cherne Industries, Inc.
DXG
Aug 19, 1985K841967DESERET THERMODILUTION CARDIAC OUTPUT
Parke-Davis Co., CA
DXG
Jun 21, 1985K834059FUKUDA DENSHI EH-11
Fukuda Denshi USA, Inc.
DXG
May 28, 1985K844116CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC
Critikon Company, LLC
DXG
Apr 9, 1985K850568MODEL 78231D CARDIAC OUTPUT MODULE
Hewlett-Packard Co.
DXG
Apr 9, 1985K844997IAI PROGRAM-COMPUTER PROGRAM
Intl. Acoustics, Inc.
DXG

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