BAHA 3 POWER SOUND PROCESSOR

Hearing Aid, Bone Conduction

COCHLEAR AMERICAS

The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Baha 3 Power Sound Processor.

Pre-market Notification Details

Device IDK110996
510k NumberK110996
Device Name:BAHA 3 POWER SOUND PROCESSOR
ClassificationHearing Aid, Bone Conduction
Applicant COCHLEAR AMERICAS 13059 E. PEAKVIEW AVE Centennial,  CO  80111
ContactSean Bundy
CorrespondentSean Bundy
COCHLEAR AMERICAS 13059 E. PEAKVIEW AVE Centennial,  CO  80111
Product CodeLXB  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-11
Decision Date2011-05-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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09321502021197 K110996 000
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09321502021302 K110996 000
09321502040211 K110996 000
09321502034654 K110996 000

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