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FDA 510(k)

Cochlear Baha SoundArc

K-Number: K171088 · 2017-06-07

Decision Date2017-06-07
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Cochlear Baha SoundArc is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K171088. 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 SoundArc?

Cochlear Baha SoundArc is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Cochlear Americas. The 510(k) number is K171088.

When did Cochlear Baha SoundArc receive FDA 510(k) clearance?

Cochlear Baha SoundArc received FDA 510(k) clearance on 2017-06-07, under 510(k) number K171088.

Who is the listed applicant for Cochlear Baha SoundArc?

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 SoundArc?

The FDA product code for Cochlear Baha SoundArc is LXB.

Other records listing Cochlear Americas as applicant

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.

View all 17 devices →

Related Devices (Code: LXB)

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.

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.