Medical Device Manufacturer · US , Mchenry , IL

General Electric Co. - FDA 510(k) Cleared Devices

254 submissions · 254 cleared · Since 1976

254

Total

254

Cleared

0

Denied

FDA 510(k) Regulatory Record - General Electric Co. Cardiovascular ✕

15 devices

1-12 of 15

Cleared Nov 29, 1988

TRANSESOPHAGEAL ECHO TRANSDUCER

Cardiovascular · 76d

Cleared Jun 01, 1988

APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300

Cardiovascular · 292d

Cleared Mar 02, 1988

RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.

Cardiovascular · 315d

Cleared Oct 20, 1987

RT5000 ECHOCARDIOGRAPHY #H4100C/CE

Cardiovascular · 238d

Cleared Dec 29, 1981

MICRO-PREPROCESSOR UNIT

Cardiovascular · 71d

Cleared Mar 27, 1981

PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE

Cardiovascular · 7d

Cleared Mar 20, 1981

Cardiovascular · 39d

Cleared Nov 26, 1980

PDS THERMAL DILUTION CARDIAC MODULE(OUT)

Cardiovascular · 64d

Cleared Sep 26, 1980

ECG RECALL & EDIT PRODUCT VERSION-A3601

Cardiovascular · 23d

Cleared Aug 27, 1980

MICRO-PROCESSOR UNIT #A3600AC

Cardiovascular · 30d

Cleared Aug 20, 1980

PDS COMPUTER UNIT/VIDEO TERMINAL

Cardiovascular · 23d

Cleared Jan 12, 1978

ARRHYTHMIA MODULE

Cardiovascular · 16d