DXG · Class II · 21 CFR 870.1435

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

Leading manufacturers include Edwards Lifesciences, LLC, Hewlett-Packard Co. and Transonic Systems, Inc..

177
Total
177
Cleared
130d
Avg days
1976
Since
177 devices
49–72 of 177
Cleared Jul 03, 1990
CARDIAC OUTPUT COMPUTER, MODEL COM-3
K896930
Baxter Healthcare Corp
Cardiovascular · 204d
Cleared Mar 13, 1990
NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM
K897004
Advanced Technology Laboratories, Inc.
Cardiovascular · 85d
Cleared Jun 20, 1989
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
K893392
Baxter Healthcare Corp
Cardiovascular · 50d
Cleared Apr 25, 1989
TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA
K884122
S & W Medico Teknik
Cardiovascular · 207d
Cleared Aug 19, 1988
3000 PHYSIOLOGICAL MONITOR
K880301
Datascope Corp.
Cardiovascular · 207d
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 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 Jan 02, 1987
2200I PHYSIOLOGICAL MONITOR
K863308
Datascope Corp.
Cardiovascular · 130d
Cleared Aug 18, 1986
MODEL SP1465 CARDIAC OUTPUT COMPUTER
K861092
Gould, Inc.
Cardiovascular · 147d
Cleared Dec 04, 1985
ARRHYTHMIA REVIEW STATION
K854136
Marquette Electronics, Inc.
Cardiovascular · 55d
Cleared Aug 19, 1985
DESERET THERMODILUTION CARDIAC OUTPUT
K841967
Parke-Davis Co.
Cardiovascular · 461d
Cleared Jun 21, 1985
FUKUDA DENSHI EH-11
K834059
Fukuda Denshi USA, Inc.
Cardiovascular · 574d
Cleared May 28, 1985
CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC
K844116
Critikon Company, LLC
Cardiovascular · 217d
Cleared Apr 09, 1985
MODEL 78231D CARDIAC OUTPUT MODULE
K850568
Hewlett-Packard Co.
Cardiovascular · 56d
Cleared Mar 06, 1985
ELECATH CARDIAC OUTPUT COMPUTER
K844682
Electro-Catheter Corp.
Cardiovascular · 96d
Cleared Feb 13, 1985
COMPUTER
K844665
Burdick Corp.
Cardiovascular · 75d
Cleared Feb 01, 1985
CARDIAC COMPUTER SP1445
K843555
Gould, Inc.
Cardiovascular · 144d
Cleared Jan 15, 1985
RIGHT VENTRICULAR EJECTION FRACTION-
K842105
American Edwards Laboratories
Cardiovascular · 235d
Cleared Jan 14, 1985
SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER
K841401
American Edwards Laboratories
Cardiovascular · 286d
Cleared Nov 20, 1984
RECOMED CARDIAC OUTPUT METER 236067-
K840439
Litton Medical Electronics
Cardiovascular · 293d
Cleared Nov 20, 1984
ELECATH VENTRICULAR PACING THERMAL DILUTION CATH
K844022
Electro-Catheter Corp.
Cardiovascular · 36d