DXG · Class II · 21 CFR 870.1435

FDA Product Code DXG: Computer, Diagnostic, Pre-programmed, Single-function

Leading manufacturers include Edwards Lifesciences, LLC, Lidco, Ltd. and Hewlett-Packard Co..

177
Total
177
Cleared
130d
Avg days
1976
Since
177 devices
73–96 of 177
Cleared Jun 16, 1988
WITT BIOMEDICAL VX-80
K880258
Witt Biomedical Corporation
Cardiovascular · 146d
Cleared Jun 15, 1988
MX1002 CABLE-CAL TM
K880696
Medex, Inc.
Cardiovascular · 114d
Cleared May 31, 1988
HORIZON 9000
K875167
Mennen Medical, Inc.
Cardiovascular · 167d
Cleared Sep 15, 1987
THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
K872529
American Edwards Laboratories
Cardiovascular · 81d
Cleared Jun 16, 1987
MODEL 617 CARDIAC OUTPUT COMPUTER
K870375
Omnimed B.V.
Cardiovascular · 138d
Cleared May 28, 1987
IMS-2000S STRESS MONITOR
K871659
Integrated Medical Systems, Inc.
Cardiovascular · 30d
Cleared May 06, 1987
IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM
K870934
Integrated Medical Systems, Inc.
Cardiovascular · 58d
Cleared Apr 20, 1987
SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM
K865101
Spectramed, Inc.
Cardiovascular · 111d
Cleared Apr 10, 1987
HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER
K861505
American Medical Equipment, Inc.
Cardiovascular · 352d
Cleared Mar 10, 1987
CARDIOMAX-II
K861543
Columbus Instruments Intl. Corp.
Cardiovascular · 320d
Cleared Feb 19, 1987
MTC 6210A CARDIAC OUTPUT COMPUTER
K854371
Nihon Kohden America, Inc.
Cardiovascular · 478d
Cleared Feb 19, 1987
KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263
K862261
Kontron Instruments, Inc.
Cardiovascular · 251d
Cleared Feb 19, 1987
BIOMA 2000
K862808
E.B.S., Inc.
Cardiovascular · 211d
Cleared Jan 06, 1987
MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH
K863153
Ocg Technology, Inc.
Cardiovascular · 144d
Cleared Jan 02, 1987
2200I PHYSIOLOGICAL MONITOR
K863308
Datascope Corp.
Cardiovascular · 130d
Cleared Nov 25, 1986
D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM
K863230
Dextra Medical, Inc.
Cardiovascular · 96d
Cleared Nov 25, 1986
D100 COMPUTER CARDIAC ANALYSIS SYSTEM
K863231
Dextra Medical, Inc.
Cardiovascular · 96d
Cleared Aug 18, 1986
MODEL SP1465 CARDIAC OUTPUT COMPUTER
K861092
Gould, Inc.
Cardiovascular · 147d
Cleared May 20, 1986
QMED SYSTEM 2150
K861437
Qmed, Inc.
Cardiovascular · 33d
Cleared Apr 23, 1986
MODIFIED CHERNE CAD DETECTOR
K860015
Cherne Industries, Inc.
Cardiovascular · 110d
Cleared Jan 13, 1986
MODEL 3000 OPTICATH COMPUTER
K853018
Oximetrix, Inc.
Cardiovascular · 180d
Cleared Dec 04, 1985
ARRHYTHMIA REVIEW STATION
K854136
Marquette Electronics, Inc.
Cardiovascular · 55d
Cleared Sep 25, 1985
CVERNE CAD DETECTOR
K852900
Cherne Industries, Inc.
Cardiovascular · 78d
Cleared Aug 19, 1985
DESERET THERMODILUTION CARDIAC OUTPUT
K841967
Parke-Davis Co.
Cardiovascular · 461d