FDA 510(k)

MDHearingAid app, MDHearingAid Smart hearing aids

Número K: K220303 · 2022-08-04

Data da decisão2022-08-04

Código do produtoQDD

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

MDHearingAid app, MDHearingAid Smart hearing aids is the device name listed in this FDA 510(k) record. The listed applicant is Mdhearingaid. It received FDA 510(k) clearance on 2022-08-04 under 510(k) number K220303. The device is classified under product code QDD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MDHearingAid app, MDHearingAid Smart hearing aids?

MDHearingAid app, MDHearingAid Smart hearing aids is a medical device that received FDA 510(k) clearance on 2022-08-04. The listed applicant is Mdhearingaid. The 510(k) number is K220303.

When did MDHearingAid app, MDHearingAid Smart hearing aids receive FDA 510(k) clearance?

MDHearingAid app, MDHearingAid Smart hearing aids received FDA 510(k) clearance on 2022-08-04, under 510(k) number K220303.

Who is the listed applicant for MDHearingAid app, MDHearingAid Smart hearing aids?

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

What is the FDA product code for MDHearingAid app, MDHearingAid Smart hearing aids?

The FDA product code for MDHearingAid app, MDHearingAid Smart hearing aids is QDD.

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