FDA 510(k)

Cochlear Baha SoundArc

Número K: K171088 · 2017-06-07

Data da decisão2017-06-07

Código do produtoLXB

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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