BEHIND-THE-EAR HEARING AID 2000

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 2000.

Pre-market Notification Details

Device IDK840871
510k NumberK840871
Device Name:BEHIND-THE-EAR HEARING AID 2000
ClassificationHearing Aid, Air Conduction
Applicant TELEX COMMUNICATIONS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-27
Decision Date1984-03-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.