510(k) K202171

Pulmogine Vibrating Mesh Nebulizer by Hcmed Innovations Co., Ltd. — Product Code CAF

K202171 is an FDA 510(k) premarket notification submitted by Hcmed Innovations Co., Ltd. for the device "Pulmogine Vibrating Mesh Nebulizer". The FDA issued a decision of Substantially Equivalent on July 1, 2021. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Hcmed Innovations Co., Ltd. has at least 1 other 510(k) clearance on record.