Cochlear Baha SoundArc

Hearing Aid, Bone Conduction

Cochlear Americas

The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cochlear Baha Soundarc.

Pre-market Notification Details

Device IDK171088
510k NumberK171088
Device Name:Cochlear Baha SoundArc
ClassificationHearing Aid, Bone Conduction
Applicant Cochlear Americas 13059 E. Peakview Avenue Centennial,  CO  80111
ContactBeth Murray
CorrespondentBeth Murray
Cochlear Americas 13059 E. Peakview Avenue Centennial,  CO  80111
Product CodeLXB  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-12
Decision Date2017-06-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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09321502033046 K171088 000

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