Medical Device Manufacturer · US , Champaign , IL

Mimosa Acoustics, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1998

Recent clearances: OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM, HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER, HEARID WIDEBAND MIDDLE EAR POWER ANALYZER

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mimosa Acoustics, Inc. Ear, Nose, Throat ✕

4 devices

1-4 of 4

Cleared Mar 28, 2013

OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM

Ear, Nose, Throat · 125d

Cleared Jan 04, 2007

HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER

Ear, Nose, Throat · 59d

Cleared Feb 10, 2006

HEARID WIDEBAND MIDDLE EAR POWER ANALYZER

Ear, Nose, Throat · 85d

Cleared May 20, 1998

CUB DIS II DPOAE MEASUREMENT SYSTEM

Ear, Nose, Throat · 27d