Cleared Traditional

351-AGCO BEHIND-THE-EAR HEARING AID

K933095 · Telex Communications, Inc. · Ear, Nose, Throat

Jul 1993

Decision

32d

Days

Class 1

Risk

About This 510(k) Submission

K933095 is an FDA 510(k) clearance for the 351-AGCO BEHIND-THE-EAR HEARING AID, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 26, 1993, 32 days after receiving the submission on June 24, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K933095 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 1993
Decision Date	July 26, 1993
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

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.