Cleared Traditional

STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER

K964216 · Starkey Laboratories, Inc. · Ear, Nose, Throat

Dec 1996

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K964216 is an FDA 510(k) clearance for the STARKEY TM-3, TM-5 HIGH FREQUENCY 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 December 6, 1996, 45 days after receiving the submission on October 22, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number	K964216 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 22, 1996
Decision Date	December 06, 1996
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF