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FDA 510(k)

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

K-Number: K212136 · 2021-09-29

ApplicantCochlear Americas
Decision Date2021-09-29
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App is a medical device manufactured by Cochlear Americas. It received FDA 510(k) clearance on 2021-09-29 under approval number K212136. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App?

Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App is a medical device that received FDA 510(k) clearance on 2021-09-29. It is manufactured by Cochlear Americas. The 510(k) number is K212136.

When was Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App approved by the FDA?

Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App received FDA 510(k) clearance on 2021-09-29, under approval number K212136.

What company makes Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App?

Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App is manufactured by Cochlear Americas.

What is the FDA product code for Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App?

The FDA product code for Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App is LXB.

Related Clinical Trials

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Related PubMed Literature

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Other Devices by Cochlear Americas

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Related Devices (Code: LXB)

K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationSophono, Inc. K161123Baha 5 Power Sound ProcessorCochlear Americas K153245Baha 5 Super Power Sound ProcessorCochlear Americas K171088Cochlear Baha SoundArcCochlear Americas K172460ADHEAR SystemMed-El Elektromedizinische Geraete GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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