FDA 510(k)

HWJECT Auto-disable syringe

Número K: K234024 · 2024-03-19

RequerenteAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

Data da decisão2024-03-19

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

HWJECT Auto-disable syringe is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2024-03-19 under 510(k) number K234024. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HWJECT Auto-disable syringe?

HWJECT Auto-disable syringe is a medical device that received FDA 510(k) clearance on 2024-03-19. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K234024.

When did HWJECT Auto-disable syringe receive FDA 510(k) clearance?

HWJECT Auto-disable syringe received FDA 510(k) clearance on 2024-03-19, under 510(k) number K234024.

Who is the listed applicant for HWJECT Auto-disable syringe?

The FDA 510(k) record lists Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HWJECT Auto-disable syringe?

The FDA product code for HWJECT Auto-disable syringe is FMF.

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Outros registros que listam Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. como candidato(a)

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Fonte oficial

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