Medical Device Manufacturer · US , Dayton , OH

Grandcor Medical Systems - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1986

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Grandcor Medical Systems Cardiovascular ✕

6 devices

1-6 of 6

Cleared Mar 13, 1990

GRANDCOR/CARDIOLINE ECT STRESS TESTING

Cardiovascular · 181d

Cleared Oct 17, 1988

Cardiovascular · 67d

Cleared Jun 12, 1987

CARDIO-MEGA SYSTEM

Cardiovascular · 28d

Cleared May 11, 1987

APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)

Cardiovascular · 194d

Cleared Feb 19, 1987

Cardiovascular · 59d

Cleared Jul 01, 1986

CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM

Cardiovascular · 7d