HEARING AID 365

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 Hearing Aid 365.

Pre-market Notification Details

Device IDK850243
510k NumberK850243
Device Name:HEARING AID 365
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 Received1985-01-22
Decision Date1985-03-25

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