TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II

Hearing Aid, Air Conduction

TELEX COMMUNICATIONS, INC.

The following data is part of a premarket notification filed by Telex Communications, Inc. with the FDA for Telex In-the-ear Custom Hearing Aid With Threshold Compression-ii.

Pre-market Notification Details

Device IDK964639
510k NumberK964639
Device Name:TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
ClassificationHearing Aid, Air Conduction
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 CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-19
Decision Date1997-01-21
Summary:summary

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