Medical Device Manufacturer · US , Minnetonka , MN

Audioscience, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1990

Recent clearances: PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES

4

Total

4

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Mar 04, 1994

PRIZM HEARING SYSTEM, MODEL POWER BTE

Ear, Nose, Throat · 78d

Cleared Aug 09, 1993

PRIZM HEARING SYSTEM

Ear, Nose, Throat · 180d

Cleared Jun 10, 1992

PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES

Ear, Nose, Throat · 20d

Cleared Oct 31, 1990

PRIZM HEARING SYSTEM

Ear, Nose, Throat · 125d