FDA 510(k)

Syringe with permanently attached needle

Número K: K213158 · 2022-07-21

RequerenteBerpu Medical Technology Co., Ltd.

Data da decisão2022-07-21

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Syringe with permanently attached needle is the device name listed in this FDA 510(k) record. The listed applicant is Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-21 under 510(k) number K213158. 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 Syringe with permanently attached needle?

Syringe with permanently attached needle is a medical device that received FDA 510(k) clearance on 2022-07-21. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K213158.

When did Syringe with permanently attached needle receive FDA 510(k) clearance?

Syringe with permanently attached needle received FDA 510(k) clearance on 2022-07-21, under 510(k) number K213158.

Who is the listed applicant for Syringe with permanently attached needle?

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

What is the FDA product code for Syringe with permanently attached needle?

The FDA product code for Syringe with permanently attached needle is FMF.

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Outros registros que listam Berpu Medical Technology Co., Ltd. como candidato(a)

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Fonte oficial

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