FDA 510(k)

Bose SoundControl Hearing Aids

Номер K: K211008 · 2021-05-05

Дата решения2021-05-05

Код продуктаQDD

Консультативный комитетEN

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: QDD)

K223911Lumen 155-SFIntricon Corporation K220403Vibe SF Self-Fitting Hearing AidWsaud A/S K220303MDHearingAid app, MDHearingAid Smart hearing aidsMdhearingaid K213424Jabra Enhance PlusGN Hearing A/S K212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company

Официальный источник

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