510(k) K170886

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

K170886 is an FDA 510(k) premarket notification submitted by Shenzhen Homed Medical Device Co., Ltd. for the device "HOMED Mesh Nebulizer". The FDA issued a decision of Substantially Equivalent on June 21, 2018. 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.