Cleared Traditional

TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER

K915383 · Telex Communications, Inc. · Ear, Nose, Throat
Jan 1992
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K915383 is an FDA 510(k) clearance for the TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER, 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 January 17, 1992, 49 days after receiving the submission on November 29, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number K915383 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 1991
Decision Date January 17, 1992
Days to Decision 49 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

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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