Cleared Traditional

K954579 - TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION
(FDA 510(k) Clearance)

K954579 · Telex Communications, Inc. · Ear, Nose, Throat

Dec 1995

Decision

67d

Days

Class 1

Risk

K954579 is an FDA 510(k) clearance for the TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION, 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 December 8, 1995, 67 days after receiving the submission on October 2, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K954579 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 1995
Decision Date	December 08, 1995
Days to Decision	67 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.