TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER

Hearing Aid, Group And Auditory Trainer

TELEX COMMUNICATIONS, INC.

The following data is part of a premarket notification filed by Telex Communications, Inc. with the FDA for Tdr-4 Monaural Hearing Aid/wireless Fm Receiver.

Pre-market Notification Details

Device IDK915383
510k NumberK915383
Device Name:TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER
ClassificationHearing Aid, Group And Auditory Trainer
Applicant TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis,  MN  55420
ContactThomas Lake
CorrespondentThomas Lake
TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis,  MN  55420
Product CodeEPF  
CFR Regulation Number874.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-29
Decision Date1992-01-17

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