FDA 510(k)

Portable mesh nebulizer (JM821)

K-Number: K244035 · 2025-09-19

ApplicantShenzhen Jermei Medical Device Technology Co., Ltd.

Decision Date2025-09-19

Product CodeCAF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Portable mesh nebulizer (JM821) is a medical device manufactured by Shenzhen Jermei Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under approval number K244035. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Shenzhen Jermei Medical Device Technology Co., Ltd.. The 510(k) number is K244035.

When was Portable mesh nebulizer (JM821) approved by the FDA?

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

What company makes Portable mesh nebulizer (JM821)?

Portable mesh nebulizer (JM821) is manufactured by Shenzhen Jermei Medical Device Technology Co., Ltd..

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.