510(k) K052438

EMG HANDLE NEBULIZER NB02 SERIES by Emg Technology Co., Ltd. — Product Code CAF

K052438 is an FDA 510(k) premarket notification submitted by Emg Technology Co., Ltd. for the device "EMG HANDLE NEBULIZER NB02 SERIES". The FDA issued a decision of Substantially Equivalent on January 31, 2006. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Emg Technology Co., Ltd. has at least 10 other 510(k) clearances on record.