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
Mar 6, 1985K844682ELECATH CARDIAC OUTPUT COMPUTER
Electro-Catheter Corp.
DXG
Feb 15, 1985K844277OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR
Omikron Scientific, Ltd., IL
DXG
Feb 13, 1985K844665COMPUTER
Burdick Corp.
DXG
Feb 1, 1985K843555CARDIAC COMPUTER SP1445
Gould, Inc.
DXG
Jan 15, 1985K842105RIGHT VENTRICULAR EJECTION FRACTION-
American Edwards Laboratories
DXG
Jan 14, 1985K841401SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER
American Edwards Laboratories
DXG
Nov 27, 1984K842706SCATAID
Sc Applied Technology, Inc.
DXG
Nov 20, 1984K844022ELECATH VENTRICULAR PACING THERMAL DILUTION CATH
Electro-Catheter Corp.
DXG
Nov 20, 1984K840439RECOMED CARDIAC OUTPUT METER 236067-
Litton Medical Electronics
DXG
Oct 2, 1984K841256MODELS 78551A 78552A
Hewlett-Packard Co.
DXG
Aug 27, 1984K842831BAIM CORONARY SINUS FLOW CALCULATOR
Electro-Catheter Corp.
DXG
Aug 23, 1984K834408TX-2 THERMAL DILUTION CARDIAC OUTPUT
Waters Instruments, Inc.
DXG
Aug 22, 1984K840009NOVA 12 CARDIAC OUTPUT COMPUTER
Nova Medical Specialties
DXG
Aug 10, 1984K841261COMPUTER, CENTRAL PROCESSING UNIT
Nem Computer Corp.
DXG
Apr 24, 1984K833756SYSTEM 5000
Medical Graphics Corp.
DXG
Mar 22, 1984K833914CARDIAC OUTPUT SIGNAL ACQUISTION
Hewlett-Packard Co.
DXG
Mar 22, 1984K833913HEMODYNAMIC PLUG-IN MODULE 78551A
Hewlett-Packard Co.
DXG
Jan 27, 1984K832644ALPHA CARDIAC OUTPUT CARDULE #1899
Spacelabs, Inc.
DXG
Jan 10, 1984K833395SENTINEL SYSTEMS
Quantitative Medicine, Inc.
DXG
Oct 28, 1983K831967CRITIKON CARDIAC OUTPUT COMPUTER
Critikon Company, LLC
DXG
Oct 19, 1983K831057VIDEO-DILUTION TECH. MARK I INSTRUMENT
Angio Tec Corp.
DXG
Oct 14, 1983K831407CARDIAC OUTPUT COMPUTER
Ziehm International, Inc.
DXG
Jun 15, 1983K830892THERMODILUTION CARDIAC OUTPUT COMPUTER-
American Edwards Laboratories
DXG
Jun 2, 1983K830628REAL-TIME SPECTRUM ANALYZER
Diagnostic Electronics Corp.
DXG
Mar 10, 1983K830003MICRO FITNESS COMPUTER
Microfit, Inc.
DXG
Nov 1, 1982K822972IL 801 THERMALDILUTION CARDIAC OUTPUT
Instrumentation Laboratory CO
DXG
Nov 1, 1982K822903AUTOECHO
Oxford Medilog, Inc.
DXG
Oct 18, 1982K822877MODEL 78554A DATA MGMT. PLUG-IN MODULE
Hewlett-Packard Co.
DXG
Sep 21, 1982K822093STAT-SCAN
Survival Technology, Inc.
DXG
May 25, 1982K820194CARDIAC CATHERIZATION LAB MICROPROCESS
Compu-Cath Corp.
DXG
Apr 29, 1982K820820CARDIO REVUE CENTER
Diasonics, Inc.
DXG
Apr 21, 1982K820898VASCULAB SPECTRUM ANALYZER #SP25
Medasonics, Inc.
DXG
Apr 15, 1982K813223DISPOSABLE PLASTIC SYRINGE W/NEEDLE
Sam Joo Industrial Co., Ltd.
DXG
Dec 29, 1981K813222MODEL 4200 ELLESTAD STRESS TEST ANALYZER
Del Mar Avionics
DXG
Dec 29, 1981K812971CARDIOINTEGRAM
Ocg Technology, Inc.
DXG
Dec 14, 1981K813020BOMED-NCCOM
Bomed Medical Mfr., Ltd.
DXG
Dec 2, 1981K812932ANERIOD GAUZE
Abco Dealers, Inc.
DXG
Nov 16, 1981K812638DIAGNOSTIC MEDICAL COMPUTER
Diagnostic Resources, Inc.
DXG
Nov 2, 1981K812757SORENSON THERMODILUTION CARDIAC COMPUT
Sorensen Research
DXG
Oct 2, 1981K812515CARDIAC REVIEW STATION
Diasonics, Inc.
DXG
Jun 18, 1981K811560AUTOMATED PHYSIOLOGIC PROFILE MONITOR
Life Sciences Manufacturing, Inc.
DXG
Jun 12, 1981K811414BAIM CORONARY SINUS FLOW ANALYZER
Electro-Catheter Corp.
DXG
May 29, 1981K811062CAMPBRIDGE COMPUTRACE
Cambridge Instruments, Inc.
DXG
Apr 23, 1981K810851SPECTRUM ANALYZER 8000
Radionics Medical, Inc.
DXG
Mar 5, 1981K810163AM 420 MICROPROCESSOR
Honeywell, Inc.
DXG
Feb 25, 1981K810177PATIENT MONITOR MODEL CM130, 140
Honeywell, Inc.
DXG
Feb 25, 1981K810170TREND GRAPH FUNCTION BLOCK
Honeywell, Inc.
DXG
Nov 26, 1980K802316PDS THERMAL DILUTION CARDIAC MODULE(OUT)
General Electric Co.
DXG
Nov 24, 1980K802800NARCO AIR-SHEILDS SYS. 100 MONITOR SYS
Narco Air-Shields
DXG
Nov 19, 1980K802476CARDIACINDEX COMPUTER MODEL SP 1435
Gould, Inc.
DXG

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