510(k) K212395

Nebulizer by Shenzhen Homed Medical Device Co., Ltd. — Product Code CAF

K212395 is an FDA 510(k) premarket notification submitted by Shenzhen Homed Medical Device Co., Ltd. for the device "Nebulizer". The FDA issued a decision of Substantially Equivalent on March 25, 2022. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Shenzhen Homed Medical Device Co., Ltd. has at least 3 other 510(k) clearances on record.