FDA 510(k)

Disposable Endoscope Valves Set (AF series)

Número K: K241285 · 2024-10-01

RequerenteAlton (Shanghai) Medical Instruments Co., Ltd.

Data da decisão2024-10-01

Código do produtoODC

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Endoscope Valves Set (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 2024-10-01 under 510(k) number K241285. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Endoscope Valves Set (AF series)?

Disposable Endoscope Valves Set (AF series) is a medical device that received FDA 510(k) clearance on 2024-10-01. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K241285.

When did Disposable Endoscope Valves Set (AF series) receive FDA 510(k) clearance?

Disposable Endoscope Valves Set (AF series) received FDA 510(k) clearance on 2024-10-01, under 510(k) number K241285.

Who is the listed applicant for Disposable Endoscope Valves Set (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 Endoscope Valves Set (AF series)?

The FDA product code for Disposable Endoscope Valves Set (AF series) is ODC.

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

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Dispositivos Relacionados (Código: ODC)

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Fonte oficial

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