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FDA 510(k)

Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)

K-Number: K254171 · 2026-09-18

ApplicantShenzhen Mericonn Technology Co., Ltd.
Decision Date2026-09-18
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mericonn Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K254171. 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 Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)?

Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Shenzhen Mericonn Technology Co., Ltd.. The 510(k) number is K254171.

When did Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) receive FDA 510(k) clearance?

Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) received FDA 510(k) clearance on 2026-09-18, under 510(k) number K254171.

Who is the listed applicant for Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)?

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

What is the FDA product code for Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)?

The FDA product code for Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) is CAF.

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Official Source

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