MAICO MA800 AUDIOMETER

Audiometer

MAICO HEARING INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Maico Ma800 Audiometer.

Pre-market Notification Details

Device IDK911368
510k NumberK911368
Device Name:MAICO MA800 AUDIOMETER
ClassificationAudiometer
Applicant MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis,  MN  55439 -2029
ContactLois Donnay
CorrespondentLois Donnay
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 Received1991-03-28
Decision Date1991-06-26

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