Baha 5 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 5 Power Sound Processor.

Pre-market Notification Details

Device IDK161123
510k NumberK161123
Device Name:Baha 5 Power Sound Processor
ClassificationHearing Aid, Bone Conduction
Applicant Cochlear Americas 13059 E. Peakview Avenue Centennial,  CO  80111
ContactLaura Blair
CorrespondentLaura Blair
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 Received2016-04-21
Decision Date2016-05-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09321502044097 K161123 000
09321502034593 K161123 000
09321502034609 K161123 000
09321502034616 K161123 000
09321502034623 K161123 000
09321502034630 K161123 000
09321502034661 K161123 000
09321502038959 K161123 000
09321502038966 K161123 000
09321502034586 K161123 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.