Medical Device Manufacturer · US , Mchenry , IL

Birtcher Corp. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 1976

27

Total

27

Cleared

0

Denied

FDA 510(k) Regulatory Record - Birtcher Corp. Cardiovascular ✕

10 devices

1-10 of 10

Cleared May 18, 1988

Cardiovascular · 50d

Cleared Apr 09, 1985

CARDIO-NEC MODEL 365

Cardiovascular · 168d

Cleared Mar 06, 1985

CARDIO ANALYZER MODEL 380

Cardiovascular · 134d

Cleared Jan 18, 1985

CARDIOPAC DEFIBRILLATOR 444

Cardiovascular · 87d

Cleared Dec 30, 1982

ELECTROCARDIOGRAPH #334

Cardiovascular · 37d

Cleared Jul 30, 1982

AUTOMATIC SINGLE CHANNEL ECG #399

Cardiovascular · 35d

Cleared Jul 08, 1982

35MM ANGIOGRAM VIEWER ANALYZER

Cardiovascular · 51d

Cleared May 25, 1982

CARDIOCASSETTE II #363

Cardiovascular · 11d

Cleared Jan 31, 1977

SIMULATOR, 10 LEAD ECG

Cardiovascular · 81d

Cleared Jan 14, 1977

ELECTROCARDIOGRAPH MODEL 344

Cardiovascular · 4d