Medical Device Manufacturer · US , Eden Prairie , MN

Interacoustics A/S, Assens - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2002

Recent clearances: DPOAE20 , ECLIPSE, REM440

4

Total

4

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared May 30, 2006

DPOAE20 , ECLIPSE

Ear, Nose, Throat · 90d

Cleared Apr 29, 2005

Ear, Nose, Throat · 60d

Cleared Mar 28, 2003

Ear, Nose, Throat · 85d

Cleared Oct 11, 2002

AUDIOTRAVELLER, MODEL AA222

Ear, Nose, Throat · 56d