OTICON HEARING AID MODEL I52

Hearing Aid, Air Conduction

OTICON CORP.

The following data is part of a premarket notification filed by Oticon Corp. with the FDA for Oticon Hearing Aid Model I52.

Pre-market Notification Details

Device IDK874651
510k NumberK874651
Device Name:OTICON HEARING AID MODEL I52
ClassificationHearing Aid, Air Conduction
Applicant OTICON CORP. 29 SCHOOLHOUSE RD. P.O. BOX 6724 Somerset,  NJ  08873
ContactPreben Brunved
CorrespondentPreben Brunved
OTICON CORP. 29 SCHOOLHOUSE RD. P.O. BOX 6724 Somerset,  NJ  08873
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-13
Decision Date1988-01-19

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