Medical Device Manufacturer · DK , Taastrup

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

6 submissions · 6 cleared · Since 2004

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gn Otometrics A/S Ear, Nose, Throat ✕

3 devices

1-3 of 3

Cleared Apr 28, 2011

GN OTOMETRICS TYPE 1053 FREEFIT

Ear, Nose, Throat · 87d

Cleared May 03, 2006

SPEECHLINK 100 TYPE 1053

Ear, Nose, Throat · 13d

Cleared Mar 31, 2004

OTOFLEX 100 TYE 1012

Ear, Nose, Throat · 132d