SERIES MR IN-THE-EAR CUSTOM HEARING AID

Hearing Aid, Air Conduction

MAICO HEARING INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Series Mr In-the-ear Custom Hearing Aid.

Pre-market Notification Details

Device IDK840825
510k NumberK840825
Device Name:SERIES MR IN-THE-EAR CUSTOM HEARING AID
ClassificationHearing Aid, Air Conduction
Applicant MAICO HEARING INSTRUMENTS, 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 Received1984-02-24
Decision Date1984-03-30

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