Cleared Traditional

K791071 - MODEL MA3 BEHIND-THE-EAR MASKER/HEARING (FDA 510(k) Clearance)

K791071 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
Jul 1979
Decision
21d
Days
Class 2
Risk

K791071 is an FDA 510(k) clearance for the MODEL MA3 BEHIND-THE-EAR MASKER/HEARING. This device is classified as a Masker, Tinnitus (Class II - Special Controls, product code KLW).

Submitted by Starkey Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 3, 1979, 21 days after receiving the submission on June 12, 1979.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number K791071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1979
Decision Date July 03, 1979
Days to Decision 21 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -

Device Classification

Product Code KLW - Masker, Tinnitus
Device Class Class II - Special Controls
CFR Regulation 21 CFR 874.3400