FDA 510(k)

Portable mesh nebulizer (JM821)

Número K: K244035 · 2025-09-19

RequerenteShenzhen Jermei Medical Device Technology Co., Ltd.

Data da decisão2025-09-19

Código do produtoCAF

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Portable mesh nebulizer (JM821) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jermei Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K244035. 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 Portable mesh nebulizer (JM821)?

Portable mesh nebulizer (JM821) is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Shenzhen Jermei Medical Device Technology Co., Ltd.. The 510(k) number is K244035.

When did Portable mesh nebulizer (JM821) receive FDA 510(k) clearance?

Portable mesh nebulizer (JM821) received FDA 510(k) clearance on 2025-09-19, under 510(k) number K244035.

Who is the listed applicant for Portable mesh nebulizer (JM821)?

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

What is the FDA product code for Portable mesh nebulizer (JM821)?

The FDA product code for Portable mesh nebulizer (JM821) is CAF.

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