Cleared Traditional

TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION

K982683 · Telex Communications, Inc. · Ear, Nose, Throat
Oct 1998
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K982683 is an FDA 510(k) clearance for the TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION, 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 October 6, 1998, 67 days after receiving the submission on July 31, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number K982683 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1998
Decision Date October 06, 1998
Days to Decision 67 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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