Cleared Traditional

STARKEY TM AIR CONDUCTION TINNITUS MASKER

K963838 · Starkey Laboratories, Inc. · Ear, Nose, Throat

Nov 1996

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K963838 is an FDA 510(k) clearance for the STARKEY TM AIR CONDUCTION TINNITUS MASKER, a Masker, Tinnitus (Class II — Special Controls, product code KLW), submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on November 26, 1996, 63 days after receiving the submission on September 24, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number	K963838 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 1996
Decision Date	November 26, 1996
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF