FDA 510(k)

Concha Sol Hearing Aids (CL-1001)

Número K: K233747 · 2024-03-15

Data da decisão2024-03-15

Código do produtoQUH

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Concha Sol Hearing Aids (CL-1001) is the device name listed in this FDA 510(k) record. The listed applicant is Concha Labs. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K233747. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Concha Sol Hearing Aids (CL-1001)?

Concha Sol Hearing Aids (CL-1001) is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Concha Labs. The 510(k) number is K233747.

When did Concha Sol Hearing Aids (CL-1001) receive FDA 510(k) clearance?

Concha Sol Hearing Aids (CL-1001) received FDA 510(k) clearance on 2024-03-15, under 510(k) number K233747.

Who is the listed applicant for Concha Sol Hearing Aids (CL-1001)?

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

What is the FDA product code for Concha Sol Hearing Aids (CL-1001)?

The FDA product code for Concha Sol Hearing Aids (CL-1001) is QUH.

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