Omega Point Systems, LLC is one of 24536 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Omega Point Systems, LLC - FDA 510(k) Cleared Devices
Recent clearances: BREATHKEY MODEL G10/BREATHKEY MODEL G30X
1
Total
1
Cleared
0
Denied
Omega Point Systems, LLC has 1 FDA 510(k) cleared medical devices. Based in Cincinnati, US.
Historical record: 1 cleared submissions from 2005 to 2005. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Omega Point Systems, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Tuv America, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Omega Point Systems, LLC
1 devices