DUALINE 100 BTE

Hearing Aid, Air Conduction

BERNAFON-MAICO, INC.

The following data is part of a premarket notification filed by Bernafon-maico, Inc. with the FDA for Dualine 100 Bte.

Pre-market Notification Details

Device IDK973948
510k NumberK973948
Device Name:DUALINE 100 BTE
ClassificationHearing Aid, Air Conduction
Applicant BERNAFON-MAICO, INC. 9675 WEST 76TH ST. Eden Prairie,  MN  55344
ContactRay Enroth
CorrespondentRay Enroth
BERNAFON-MAICO, INC. 9675 WEST 76TH ST. Eden Prairie,  MN  55344
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-16
Decision Date1997-10-28

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