Cleared Traditional

BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP

K931134 · Telex Communications, Inc. · Ear, Nose, Throat

Apr 1993

Decision

40d

Days

Class 1

Risk

About This 510(k) Submission

K931134 is an FDA 510(k) clearance for the BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP, 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 April 14, 1993, 40 days after receiving the submission on March 5, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K931134 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 1993
Decision Date	April 14, 1993
Days to Decision	40 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.