Cleared Traditional

TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40

K961143 · Telex Communications, Inc. · Ear, Nose, Throat

May 1996

Decision

47d

Days

Class 1

Risk

About This 510(k) Submission

K961143 is an FDA 510(k) clearance for the TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40, 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 May 7, 1996, 47 days after receiving the submission on March 21, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K961143 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 1996
Decision Date	May 07, 1996
Days to Decision	47 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.