Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App

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 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App.

Pre-market Notification Details

Device IDK212136
510k NumberK212136
Device Name:Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
ClassificationHearing Aid, Bone Conduction
Applicant Cochlear Americas 10350 Park Meadows Dr Lone Tree,  CO  80124
ContactWhitney Alexander
CorrespondentWhitney Alexander
Cochlear Americas 10350 Park Meadows Dr Lone Tree,  CO  80124
Product CodeLXB  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-08
Decision Date2021-09-29

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