Medical Device Manufacturer · US , Mchenry , IL

Scole Engineering Co. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1977

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Scole Engineering Co. Cardiovascular ✕

4 devices

1-4 of 4

Cleared Jan 13, 1994

SCOLE 300 ECG RECORDER

Cardiovascular · 540d

Cleared Jan 14, 1983

ALTA II ECG RECORDER

Cardiovascular · 161d

Cleared Oct 04, 1982

ALTA III ECG RECORDER

Cardiovascular · 59d

Cleared May 18, 1977

RECORDING UNIT, MODEL 1445

Cardiovascular · 13d