FDA 510(k)

Tipo I, Tipo II, Tipo III, Tipo IV

Número K: K172331 · 2018-03-02

RequerenteLepu Medical Technology (Beijing) Co., Ltd.

Data da decisão2018-03-02

Código do produtoDYB

Comité consultivoCV

DecisãoUnknown

Resumo do dispositivo

Type I, Type II, Type III, Type IV is the device name listed in this FDA 510(k) record. The listed applicant is Lepu Medical Technology (Beijing) Co., Ltd.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K172331. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the Type I, Type II, Type III, Type IV?

Type I, Type II, Type III, Type IV is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Lepu Medical Technology (Beijing) Co., Ltd.. The 510(k) number is K172331.

When did Type I, Type II, Type III, Type IV receive FDA 510(k) clearance?

Type I, Type II, Type III, Type IV received FDA 510(k) clearance on 2018-03-02, under 510(k) number K172331.

Who is the listed applicant for Type I, Type II, Type III, Type IV?

The FDA 510(k) record lists Lepu Medical Technology (Beijing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Type I, Type II, Type III, Type IV?

The FDA product code for Type I, Type II, Type III, Type IV is DYB.

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Fonte oficial

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