510(k) K043238

COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES by Emg Technology Co., Ltd. — Product Code CAF

K043238 is an FDA 510(k) premarket notification submitted by Emg Technology Co., Ltd. for the device "COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES". The FDA issued a decision of Substantially Equivalent on July 6, 2005. 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.