Cleared Traditional

TELEX TINNITUS-COMPANION

K984243 · Telex Communications, Inc. · Ear, Nose, Throat
Jan 1999
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K984243 is an FDA 510(k) clearance for the TELEX TINNITUS-COMPANION, a Masker, Tinnitus (Class II — Special Controls, product code KLW), submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 21, 1999, 55 days after receiving the submission on November 27, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number K984243 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 1998
Decision Date January 21, 1999
Days to Decision 55 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code KLW — Masker, Tinnitus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3400