FDA 510(k)

Aduro Comb (Modelo: SZ-22, SZ-22A, SZ-22B)

Número K: K230597 · 2023-04-28

RequerenteLight Tree Ventures Europe B.V.

Data da decisão2023-04-28

Código do produtoOAP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) is the device name listed in this FDA 510(k) record. The listed applicant is Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2023-04-28 under 510(k) number K230597. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)?

Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) is a medical device that received FDA 510(k) clearance on 2023-04-28. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K230597.

When did Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) receive FDA 510(k) clearance?

Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) received FDA 510(k) clearance on 2023-04-28, under 510(k) number K230597.

Who is the listed applicant for Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)?

The FDA 510(k) record lists Light Tree Ventures Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)?

The FDA product code for Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) is OAP.

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Fonte oficial

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