510(k) K254171

Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) by Shenzhen Mericonn Technology Co., Ltd. — Product Code CAF

K254171 is an FDA 510(k) premarket notification submitted by Shenzhen Mericonn Technology Co., Ltd. for the device "Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)". The FDA issued a decision of Substantially Equivalent on September 18, 2026. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Shenzhen Mericonn Technology Co., Ltd. has at least 2 other 510(k) clearances on record.