AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID

Audiometer

MAICO HEARING INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Audiometer Ai1, Me1 And Sa1 & Master Hearing Aid.

Pre-market Notification Details

Device IDK890993
510k NumberK890993
Device Name:AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
ClassificationAudiometer
Applicant MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis,  MN  55439 -2029
ContactDuane Smedsrud
CorrespondentDuane Smedsrud
MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis,  MN  55439 -2029
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-27
Decision Date1989-10-12

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