FDA 510(k)

Bose SoundControl Hearing Aids

N.º K: K211008 · 2021-05-05

Fecha de decisión2021-05-05

Código de productoQDD

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Bose SoundControl Hearing Aids is the device name listed in this FDA 510(k) record. The listed applicant is Bose Corporation. It received FDA 510(k) clearance on 2021-05-05 under 510(k) number K211008. The device is classified under product code QDD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Bose SoundControl Hearing Aids?

Bose SoundControl Hearing Aids is a medical device that received FDA 510(k) clearance on 2021-05-05. The listed applicant is Bose Corporation. The 510(k) number is K211008.

When did Bose SoundControl Hearing Aids receive FDA 510(k) clearance?

Bose SoundControl Hearing Aids received FDA 510(k) clearance on 2021-05-05, under 510(k) number K211008.

Who is the listed applicant for Bose SoundControl Hearing Aids?

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

What is the FDA product code for Bose SoundControl Hearing Aids?

The FDA product code for Bose SoundControl Hearing Aids is QDD.

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Fuente oficial

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