COMPUTER AUDIOMETER - MA25

Audiometer

MAICO HEARING INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Computer Audiometer - Ma25.

Pre-market Notification Details

Device IDK780269
510k NumberK780269
Device Name:COMPUTER AUDIOMETER - MA25
ClassificationAudiometer
Applicant MAICO HEARING INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-02-21
Decision Date1978-02-27

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