Computer, Diagnostic, Pre-Programmed, Single-Function

FDA product code DXG · 170 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1435
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-19 – 2026-02-13

DXG 1984-11-20

ELECATH VENTRICULAR PACING THERMAL DILUTION CATH

Applicant Electro-Catheter Corp.

K number K844022

View details →

DXG 1984-11-20

RECOMED CARDIAC OUTPUT METER 236067-

Applicant Litton Medical Electronics

K number K840439

View details →

DXG 1984-10-02

MODELS 78551A 78552A

Applicant Hewlett-Packard Co.

K number K841256

View details →

DXG 1984-08-27

BAIM CORONARY SINUS FLOW CALCULATOR

Applicant Electro-Catheter Corp.

K number K842831

View details →

DXG 1984-08-23

TX-2 THERMAL DILUTION CARDIAC OUTPUT

Applicant Waters Instruments, Inc.

K number K834408

View details →

DXG 1984-08-22

NOVA 12 CARDIAC OUTPUT COMPUTER

Applicant Nova Medical Specialties

K number K840009

View details →

DXG 1984-08-10

COMPUTER, CENTRAL PROCESSING UNIT

Applicant Nem Computer Corp.

K number K841261

View details →

DXG 1984-04-24

SYSTEM 5000

Applicant Medical Graphics Corp.

K number K833756

View details →

DXG 1984-03-22

CARDIAC OUTPUT SIGNAL ACQUISTION

Applicant Hewlett-Packard Co.

K number K833914

View details →

DXG 1984-03-22

HEMODYNAMIC PLUG-IN MODULE 78551A

Applicant Hewlett-Packard Co.

K number K833913

View details →

DXG 1984-01-27

ALPHA CARDIAC OUTPUT CARDULE #1899

Applicant Spacelabs, Inc.

K number K832644

View details →

DXG 1984-01-10

SENTINEL SYSTEMS

Applicant Quantitative Medicine, Inc.

K number K833395

View details →

DXG 1983-10-28

CRITIKON CARDIAC OUTPUT COMPUTER

Applicant Critikon Company, LLC

K number K831967

View details →

DXG 1983-10-19

VIDEO-DILUTION TECH. MARK I INSTRUMENT

Applicant Angio Tec Corp.

K number K831057

View details →

DXG 1983-10-14

CARDIAC OUTPUT COMPUTER

Applicant Ziehm International, Inc.

K number K831407

View details →

DXG 1983-06-15

THERMODILUTION CARDIAC OUTPUT COMPUTER-

Applicant American Edwards Laboratories

K number K830892

View details →

DXG 1983-06-02

REAL-TIME SPECTRUM ANALYZER

Applicant Diagnostic Electronics Corp.

K number K830628

View details →

DXG 1983-03-10

MICRO FITNESS COMPUTER

Applicant Microfit, Inc.

K number K830003

View details →

DXG 1982-11-01

IL 801 THERMALDILUTION CARDIAC OUTPUT

Applicant Instrumentation Laboratory CO

K number K822972

View details →

DXG 1982-11-01

AUTOECHO

Applicant Oxford Medilog, Inc.

K number K822903

View details →

DXG 1982-10-18

MODEL 78554A DATA MGMT. PLUG-IN MODULE

Applicant Hewlett-Packard Co.

K number K822877

View details →

DXG 1982-09-21

STAT-SCAN

Applicant Survival Technology, Inc.

K number K822093

View details →

DXG 1982-05-25

CARDIAC CATHERIZATION LAB MICROPROCESS

Applicant Compu-Cath Corp.

K number K820194

View details →

DXG 1982-04-29

CARDIO REVUE CENTER

Applicant Diasonics, Inc.

K number K820820

View details →

DXG 1982-04-21

VASCULAB SPECTRUM ANALYZER #SP25

Applicant Medasonics, Inc.

K number K820898

View details →

DXG 1982-04-15

DISPOSABLE PLASTIC SYRINGE W/NEEDLE

Applicant Sam Joo Industrial Co., Ltd.

K number K813223

View details →

DXG 1981-12-29

MODEL 4200 ELLESTAD STRESS TEST ANALYZER

Applicant Del Mar Avionics

K number K813222

View details →

DXG 1981-12-29

CARDIOINTEGRAM

Applicant Ocg Technology, Inc.

K number K812971

View details →

DXG 1981-12-14

BOMED-NCCOM

Applicant Bomed Medical Mfr., Ltd.

K number K813020

View details →

DXG 1981-12-02

ANERIOD GAUZE

Applicant Abco Dealers, Inc.

K number K812932

View details →

DXG 1981-11-16

DIAGNOSTIC MEDICAL COMPUTER

Applicant Diagnostic Resources, Inc.

K number K812638

View details →

DXG 1981-11-02

SORENSON THERMODILUTION CARDIAC COMPUT

Applicant Sorensen Research

K number K812757

View details →

DXG 1981-10-02

CARDIAC REVIEW STATION

Applicant Diasonics, Inc.

K number K812515

View details →

DXG 1981-06-18

AUTOMATED PHYSIOLOGIC PROFILE MONITOR

Applicant Life Sciences Manufacturing, Inc.

K number K811560

View details →

DXG 1981-06-12

BAIM CORONARY SINUS FLOW ANALYZER

Applicant Electro-Catheter Corp.

K number K811414

View details →

DXG 1981-05-29

CAMPBRIDGE COMPUTRACE

Applicant Cambridge Instruments, Inc.

K number K811062

View details →

DXG 1981-04-23

SPECTRUM ANALYZER 8000

Applicant Radionics Medical, Inc.

K number K810851

View details →

DXG 1981-03-05

AM 420 MICROPROCESSOR

Applicant Honeywell, Inc.

K number K810163

View details →

DXG 1981-02-25

PATIENT MONITOR MODEL CM130, 140

Applicant Honeywell, Inc.

K number K810177

View details →

DXG 1981-02-25

TREND GRAPH FUNCTION BLOCK

Applicant Honeywell, Inc.

K number K810170

View details →

DXG 1980-11-26

PDS THERMAL DILUTION CARDIAC MODULE(OUT)

Applicant General Electric Co.

K number K802316

View details →

DXG 1980-11-24

NARCO AIR-SHEILDS SYS. 100 MONITOR SYS

Applicant Narco Air-Shields

K number K802800

View details →

DXG 1980-11-19

CARDIACINDEX COMPUTER MODEL SP 1435

Applicant Gould, Inc.

K number K802476

View details →

DXG 1980-10-10

MLC-4200 CARDIAC OUTPUT COMPUTER

Applicant Nihon Kohden America, Inc.

K number K802305

View details →

DXG 1980-09-26

BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM

Applicant Biometric Analysis Group, Inc.

K number K802198

View details →

DXG 1980-01-09

CARDIAC OUTPUT COMPUTER, M-MLC-4100

Applicant Nihon Kohden America, Inc.

K number K792678

View details →

DXG 1979-12-04

MODEL 656 ARRHYTHMIA ANALYZER

Applicant Del Mar Avionics

K number K792080

View details →

DXG 1979-11-27

VDC

Applicant Life Sciences Manufacturing, Inc.

K number K791756

View details →

DXG 1979-10-02

IPAG MICRONOVA INTERFACE #781111

Applicant Robinton Corp.

K number K791753

View details →

DXG 1979-02-27

STORAGE, DIGITAL DSC-1, CONTROL UNIT

Applicant Oxford Medilog, Inc.

K number K790288

View details →

DXG 1979-02-26

CARDIAC OUTPUT COMPUTER, MDEL 9520A

Applicant Edwards Laboratories

K number K790047

View details →

DXG 1979-01-29

CARDIAC COMPUTERS, CO-10 & CO-10R

Applicant Waters Assoc., Inc.

K number K781805

View details →

DXG 1979-01-05

LVV OPTION

Applicant Honeywell, Inc.

K number K781855

View details →

DXG 1978-09-15

AC ADAPTER:MODELS 9525,9526,9527

Applicant Edwards Laboratories

K number K781535

View details →

DXG 1977-11-28

CENTRAL MONITORING SYSTEM

Applicant Burdick Corp.

K number K772152

View details →

DXG 1977-11-28

HEARTBEATER

Applicant Dunn Instruments, Inc.

K number K771924

View details →

DXG 1977-11-22

LIGHT-PEN SYSTEM FOR QUANTI. ANALY.

Applicant Varian Assoc., Inc.

K number K772158

View details →

DXG 1977-11-03

CARDIAC OUTPUT THERMODILUTION MODULE

Applicant Abbott Laboratories

K number K771991

View details →

DXG 1977-09-30

SPHYGMOMANOMETER #1235

Applicant Sears, Roebuck & Co.

K number K771666

View details →

DXG 1977-09-28

CARDIOTHERM-500X

Applicant Columbus Instruments Intl. Corp.

K number K771718

View details →

DXG 1977-04-26

COMPUTER, CARDIAC OUTPUT, MODEL KM275

Applicant Lexington Instruments

K number K770675

View details →

DXG 1977-04-05

CARDIAC CATHETERIZATION LAB MONITOR SYS

Applicant General Electric Co.

K number K770179

View details →

DXG 1977-02-24

MONITOR, PULSE WAVE VELOCITY P607

Applicant Cyborg Corp.

K number K770330

View details →

DXG 1976-12-09

TC-1 CARDIAC OUTPUT COMPUTER

Applicant Waters Assoc., Inc.

K number K761166

View details →

DXG 1976-11-12

CARDIAC OUTPUT COMPUTER (MODEL COC-100)

Applicant B-D Electrodyne

K number K760844

View details →

DXG 1976-10-15

BATTERY OPERATED FLOW RATE COMPUTER

Applicant 3M Health Care, Sarns

K number K760756

View details →

DXG 1976-10-15

CARDIAC OUTPUT COMPUTER

Applicant Cardiopulmonary Instrumentation

K number K760600

View details →

DXG 1976-10-13

TIME-SHARING MULTIPLEXER (MODEL 78308A)

Applicant Hewlett-Packard Co.

K number K760774

View details →

DXG 1976-09-09

COMPUTER, CARDIAC OUTPUT (#SP1425)

Applicant Gould, Inc.

K number K760532

View details →

DXG 1976-07-19

COMPUTER, THERMODILUTION CARDIAC (9520)

Applicant Edwards Laboratories

K number K760192

View details →