FDA 510(k)

Pulmogine Vibrating Mesh Nebulizer

Número K: K202171 · 2021-07-01

Data da decisão2021-07-01

Código do produtoCAF

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pulmogine Vibrating Mesh Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Hcmed Innovations Co., Ltd.. It received FDA 510(k) clearance on 2021-07-01 under 510(k) number K202171. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pulmogine Vibrating Mesh Nebulizer?

Pulmogine Vibrating Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2021-07-01. The listed applicant is Hcmed Innovations Co., Ltd.. The 510(k) number is K202171.

When did Pulmogine Vibrating Mesh Nebulizer receive FDA 510(k) clearance?

Pulmogine Vibrating Mesh Nebulizer received FDA 510(k) clearance on 2021-07-01, under 510(k) number K202171.

Who is the listed applicant for Pulmogine Vibrating Mesh Nebulizer?

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

What is the FDA product code for Pulmogine Vibrating Mesh Nebulizer?

The FDA product code for Pulmogine Vibrating Mesh Nebulizer is CAF.

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Outros registros que listam Hcmed Innovations Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: CAF)

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Fonte oficial

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