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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 the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2021-09-29 under 510(k) 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. The listed applicant is Cochlear Americas. The 510(k) number is K212136.

When did Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App receive FDA 510(k) clearance?

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

Who is the listed applicant for Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App?

The FDA 510(k) record lists Cochlear Americas as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06894303Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-upRECRUITING

Other records listing Cochlear Americas as applicant

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Related Devices (Code: LXB)

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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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