FDA 510(k)

Disposable infusion set with needle

Número K: K232475 · 2024-05-10

RequerenteShandong Zhushi Pharmaceutical Group Co., Ltd.

Data da decisão2024-05-10

Código do produtoFPA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable infusion set with needle is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Zhushi Pharmaceutical Group Co., Ltd.. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K232475. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable infusion set with needle?

Disposable infusion set with needle is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Shandong Zhushi Pharmaceutical Group Co., Ltd.. The 510(k) number is K232475.

When did Disposable infusion set with needle receive FDA 510(k) clearance?

Disposable infusion set with needle received FDA 510(k) clearance on 2024-05-10, under 510(k) number K232475.

Who is the listed applicant for Disposable infusion set with needle?

The FDA 510(k) record lists Shandong Zhushi Pharmaceutical Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable infusion set with needle?

The FDA product code for Disposable infusion set with needle is FPA.

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Fonte oficial

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