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 American Edwards Laboratories.

177
Total
177
Cleared
130d
Avg days
1976
Since
177 devices
25–48 of 177
Cleared Nov 14, 1994
CONTINUOUS CARDIAC OUTPUT SYSTEM
K932414
Abbott Laboratories
Cardiovascular · 544d
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 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 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 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
Cleared Oct 02, 1984
MODELS 78551A 78552A
K841256
Hewlett-Packard Co.
Cardiovascular · 214d
Cleared Aug 27, 1984
BAIM CORONARY SINUS FLOW CALCULATOR
K842831
Electro-Catheter Corp.
Cardiovascular · 38d