FDA 510(k)

Peak flow meter

Número K: K203196 · 2021-05-26

RequerenteShanghai Sonmol Medical Equipment Co., Ltd.

Data da decisão2021-05-26

Código do produtoBZH

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Peak flow meter is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sonmol Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K203196. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Peak flow meter?

Peak flow meter is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Shanghai Sonmol Medical Equipment Co., Ltd.. The 510(k) number is K203196.

When did Peak flow meter receive FDA 510(k) clearance?

Peak flow meter received FDA 510(k) clearance on 2021-05-26, under 510(k) number K203196.

Who is the listed applicant for Peak flow meter?

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

What is the FDA product code for Peak flow meter?

The FDA product code for Peak flow meter is BZH.

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Fonte oficial

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