FDA 510(k)

DORA Disposable A.V. Fistula Needle Sets

Número K: K213015 · 2022-04-08

RequerenteBain Medical Equipment (Guangzhou) Co., Ltd.

Data da decisão2022-04-08

Código do produtoFIE

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DORA Disposable A.V. Fistula Needle Sets is the device name listed in this FDA 510(k) record. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K213015. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DORA Disposable A.V. Fistula Needle Sets?

DORA Disposable A.V. Fistula Needle Sets is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K213015.

When did DORA Disposable A.V. Fistula Needle Sets receive FDA 510(k) clearance?

DORA Disposable A.V. Fistula Needle Sets received FDA 510(k) clearance on 2022-04-08, under 510(k) number K213015.

Who is the listed applicant for DORA Disposable A.V. Fistula Needle Sets?

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

What is the FDA product code for DORA Disposable A.V. Fistula Needle Sets?

The FDA product code for DORA Disposable A.V. Fistula Needle Sets is FIE.

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Outros registros que listam Bain Medical Equipment (Guangzhou) Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: FIE)

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Fonte oficial

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