MAICO MA53

Audiometer

BERNAFON-MAICO, INC.

The following data is part of a premarket notification filed by Bernafon-maico, Inc. with the FDA for Maico Ma53.

Pre-market Notification Details

Device IDK981142
510k NumberK981142
Device Name:MAICO MA53
ClassificationAudiometer
Applicant BERNAFON-MAICO, INC. 9675 WEST 76TH ST. Eden Prairie,  MN  55344
ContactScott Savre
CorrespondentScott Savre
BERNAFON-MAICO, INC. 9675 WEST 76TH ST. Eden Prairie,  MN  55344
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-30
Decision Date1998-04-22

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