FDA 510(k)

Disposable Injection Needle AF series

Número K: K230925 · 2023-09-27

RequerenteAlton (Shanghai) Medical Instruments Co., Ltd.

Data da decisão2023-09-27

Código do produtoFBK

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Injection Needle AF series is the device name listed in this FDA 510(k) record. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-09-27 under 510(k) number K230925. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Injection Needle AF series?

Disposable Injection Needle AF series is a medical device that received FDA 510(k) clearance on 2023-09-27. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K230925.

When did Disposable Injection Needle AF series receive FDA 510(k) clearance?

Disposable Injection Needle AF series received FDA 510(k) clearance on 2023-09-27, under 510(k) number K230925.

Who is the listed applicant for Disposable Injection Needle AF series?

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

What is the FDA product code for Disposable Injection Needle AF series?

The FDA product code for Disposable Injection Needle AF series is FBK.

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Outros registros que listam Alton (Shanghai) Medical Instruments Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: FBK)

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Fonte oficial

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