Cleared Traditional

TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC

K913495 · Telex Communications, Inc. · Ear, Nose, Throat
Nov 1991
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K913495 is an FDA 510(k) clearance for the TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC, a Hearing Aid, Group And Auditory Trainer (Class II — Special Controls, product code EPF), submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 1, 1991, 87 days after receiving the submission on August 6, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number K913495 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1991
Decision Date November 01, 1991
Days to Decision 87 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EPF — Hearing Aid, Group And Auditory Trainer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3320

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