Ponto 5 SuperPower

Hearing Aid, Bone Conduction

Oticon Medical AB

The following data is part of a premarket notification filed by Oticon Medical Ab with the FDA for Ponto 5 Superpower.

Pre-market Notification Details

Device IDK213733
510k NumberK213733
Device Name:Ponto 5 SuperPower
ClassificationHearing Aid, Bone Conduction
Applicant Oticon Medical AB Datavagen 37B Askim,  SE Se-436 32
ContactAnja Ravn
CorrespondentAnja Ravn
Oticon Medical AB Datavagen 37B Askim,  SE Se-436 32
Product CodeLXB  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-26
Decision Date2021-12-16

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