Cleared Traditional

K791142 - HEARING AID, MODEL MA-1 (FDA 510(k) Clearance)

K791142 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
Sep 1979
Decision
102d
Days
Class 2
Risk

K791142 is an FDA 510(k) clearance for the HEARING AID, MODEL MA-1. 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 September 28, 1979, 102 days after receiving the submission on June 18, 1979.

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

Submission Details

510(k) Number K791142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1979
Decision Date September 28, 1979
Days to Decision 102 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