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
73–96 of 177
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
Cleared Apr 24, 1984
SYSTEM 5000
K833756
Medical Graphics Corp.
Cardiovascular · 181d
Cleared Mar 22, 1984
HEMODYNAMIC PLUG-IN MODULE 78551A
K833913
Hewlett-Packard Co.
Cardiovascular · 129d
Cleared Mar 22, 1984
CARDIAC OUTPUT SIGNAL ACQUISTION
K833914
Hewlett-Packard Co.
Cardiovascular · 129d
Cleared Jan 27, 1984
ALPHA CARDIAC OUTPUT CARDULE #1899
K832644
Spacelabs, Inc.
Cardiovascular · 175d
Cleared Oct 28, 1983
CRITIKON CARDIAC OUTPUT COMPUTER
K831967
Critikon Company, LLC
Cardiovascular · 130d
Cleared Jun 15, 1983
THERMODILUTION CARDIAC OUTPUT COMPUTER-
K830892
American Edwards Laboratories
Cardiovascular · 86d
Cleared Nov 01, 1982
AUTOECHO
K822903
Oxford Medilog, Inc.
Cardiovascular · 34d
Cleared Nov 01, 1982
IL 801 THERMALDILUTION CARDIAC OUTPUT
K822972
Instrumentation Laboratory CO
Cardiovascular · 24d
Cleared Oct 18, 1982
MODEL 78554A DATA MGMT. PLUG-IN MODULE
K822877
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Apr 29, 1982
CARDIO REVUE CENTER
K820820
Diasonics, Inc.
Cardiovascular · 36d
Cleared Apr 21, 1982
VASCULAB SPECTRUM ANALYZER #SP25
K820898
Medasonics, Inc.
Cardiovascular · 22d
Cleared Dec 29, 1981
MODEL 4200 ELLESTAD STRESS TEST ANALYZER
K813222
Del Mar Avionics
Cardiovascular · 50d
Cleared Dec 02, 1981
ANERIOD GAUZE
K812932
Abco Dealers, Inc.
Cardiovascular · 43d
Cleared Nov 02, 1981
SORENSON THERMODILUTION CARDIAC COMPUT
K812757
Sorensen Research
Cardiovascular · 33d
Cleared Oct 02, 1981
CARDIAC REVIEW STATION
K812515
Diasonics, Inc.
Cardiovascular · 30d
Cleared Jun 12, 1981
BAIM CORONARY SINUS FLOW ANALYZER
K811414
Electro-Catheter Corp.
Cardiovascular · 24d
Cleared Mar 05, 1981
AM 420 MICROPROCESSOR
K810163
Honeywell, Inc.
Cardiovascular · 42d
Cleared Feb 25, 1981
TREND GRAPH FUNCTION BLOCK
K810170
Honeywell, Inc.
Cardiovascular · 34d
Cleared Feb 25, 1981
PATIENT MONITOR MODEL CM130, 140
K810177
Honeywell, Inc.
Cardiovascular · 34d
Cleared Nov 26, 1980
PDS THERMAL DILUTION CARDIAC MODULE(OUT)
K802316
General Electric Co.
Cardiovascular · 64d
Cleared Nov 24, 1980
NARCO AIR-SHEILDS SYS. 100 MONITOR SYS
K802800
Narco Air-Shields
Cardiovascular · 18d
Cleared Nov 19, 1980
CARDIACINDEX COMPUTER MODEL SP 1435
K802476
Gould, Inc.
Cardiovascular · 41d