Medical Device Manufacturer · DK , Taastrup

Gn Otometrics A/S - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2004

Total

Cleared

Denied

Gn Otometrics A/S has 6 FDA 510(k) cleared medical devices. Based in Taastrup, DK.

Historical record: 6 cleared submissions from 2004 to 2015. Primary specialty: Neurology.

Browse the FDA 510(k) cleared devices submitted by Gn Otometrics A/S Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Intertek Testing Services and Kamm & Associates.

Gn Otometrics A/S is one of 86 FDA 510(k) medical device manufacturers from Denmark in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Gn Otometrics A/S

6 devices

1-6 of 6

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Sep 15, 2026