510(k) K101552

FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 by Foshan Care Medical Technology Co., Ltd. — Product Code CAF

K101552 is an FDA 510(k) premarket notification submitted by Foshan Care Medical Technology Co., Ltd. for the device "FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001". The FDA issued a decision of Substantially Equivalent on March 14, 2011. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Foshan Care Medical Technology Co., Ltd. has at least 3 other 510(k) clearances on record.