510(k) K092859

MERITS MODEL N SERIES NEBULIZER COMPRESSORS by Merits Health Products Co., Ltd. — Product Code CAF

K092859 is an FDA 510(k) premarket notification submitted by Merits Health Products Co., Ltd. for the device "MERITS MODEL N SERIES NEBULIZER COMPRESSORS". The FDA issued a decision of Substantially Equivalent on July 2, 2010. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Merits Health Products Co., Ltd. has at least 10 other 510(k) clearances on record.