Medical Device Manufacturer · US , Cincinnati , OH

Omega Point Systems, LLC - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2005

Recent clearances: BREATHKEY MODEL G10/BREATHKEY MODEL G30X

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Omega Point Systems, LLC Chemistry ✕

1 devices

1-1 of 1

Cleared Dec 09, 2005

BREATHKEY MODEL G10/BREATHKEY MODEL G30X

Chemistry · 66d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 27, 2026