TELEX TINNITUS-COMPANION

Masker, Tinnitus

TELEX COMMUNICATIONS, INC.

The following data is part of a premarket notification filed by Telex Communications, Inc. with the FDA for Telex Tinnitus-companion.

Pre-market Notification Details

Device IDK984243
510k NumberK984243
Device Name:TELEX TINNITUS-COMPANION
ClassificationMasker, Tinnitus
Applicant TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis,  MN  55420
ContactTom Scheller
CorrespondentTom Scheller
TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis,  MN  55420
Product CodeKLW  
CFR Regulation Number874.3400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-27
Decision Date1999-01-21
Summary:summary

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