Medical Device Manufacturer · US , Walker , MI

Ote Biomedica - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1982

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ote Biomedica Radiology ✕

3 devices

1-3 of 3

Cleared Sep 29, 1982

Radiology · 57d

Cleared Aug 06, 1982

MODEL 8000 SECTOR IMAGER SYSTEM

Radiology · 52d

Cleared Aug 06, 1982

MODEL 8100 SECTOR IMAGER

Radiology · 52d