FDA 510(k)

AdheResp Smart Breath-actuated Mesh Nebulizer

K-Number: K250583 · 2025-06-20

Decision Date2025-06-20

Product CodeCAF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

AdheResp Smart Breath-actuated Mesh Nebulizer is a medical device manufactured by Hcmed Innovations Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under approval number K250583. 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 AdheResp Smart Breath-actuated Mesh Nebulizer?

AdheResp Smart Breath-actuated Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Hcmed Innovations Co., Ltd.. The 510(k) number is K250583.

When was AdheResp Smart Breath-actuated Mesh Nebulizer approved by the FDA?

AdheResp Smart Breath-actuated Mesh Nebulizer received FDA 510(k) clearance on 2025-06-20, under approval number K250583.

What company makes AdheResp Smart Breath-actuated Mesh Nebulizer?

AdheResp Smart Breath-actuated Mesh Nebulizer is manufactured by Hcmed Innovations Co., Ltd..

What is the FDA product code for AdheResp Smart Breath-actuated Mesh Nebulizer?

The FDA product code for AdheResp Smart Breath-actuated Mesh Nebulizer is CAF.

Other Devices by Hcmed Innovations Co., Ltd.

K202171Pulmogine Vibrating Mesh Nebulizer

Related Devices (Code: 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.