OTOSONIC MINI PAS

Hearing Aid, Air Conduction

BELTONE ELECTRONICS CORP.

The following data is part of a premarket notification filed by Beltone Electronics Corp. with the FDA for Otosonic Mini Pas.

Pre-market Notification Details

Device IDK940104
510k NumberK940104
Device Name:OTOSONIC MINI PAS
ClassificationHearing Aid, Air Conduction
Applicant BELTONE ELECTRONICS CORP. 4201 WEST VICTORIA ST. Chicago,  IL  60646
ContactRobert A Kratochvil
CorrespondentRobert A Kratochvil
BELTONE ELECTRONICS CORP. 4201 WEST VICTORIA ST. Chicago,  IL  60646
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-10
Decision Date1994-03-24

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