Cleared Traditional

SM-VEGA, SM-PC, SM-AGC, SM-AGC-H

K943682 · Starkey Laboratories, Inc. · Ear, Nose, Throat

Aug 1994

Decision

22d

Days

Class 1

Risk

About This 510(k) Submission

K943682 is an FDA 510(k) clearance for the SM-VEGA, SM-PC, SM-AGC, SM-AGC-H, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 17, 1994, 22 days after receiving the submission on July 26, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K943682 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 1994
Decision Date	August 17, 1994
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ESD — Hearing Aid, Air-conduction, Prescription
Device Class	Class I — General Controls
CFR Regulation	21 CFR 874.3300
Definition	An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.