BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP

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 Behind-the-ear Hearing Aid, Telex Model 361-pp.

Pre-market Notification Details

Device IDK931134
510k NumberK931134
Device Name:BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP
ClassificationHearing Aid, Air Conduction
Applicant TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis,  MN  55420
ContactHarry Teder
CorrespondentHarry Teder
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 Received1993-03-05
Decision Date1993-04-14

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