510(k) K100380

ALTERA NEBULIZER SYSTEM, MODEL 678G1002 by Pari Respiratory Equipment, Inc. — Product Code CAF

K100380 is an FDA 510(k) premarket notification submitted by Pari Respiratory Equipment, Inc. for the device "ALTERA NEBULIZER SYSTEM, MODEL 678G1002". The FDA issued a decision of Substantially Equivalent on February 22, 2010. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Pari Respiratory Equipment, Inc. has at least 9 other 510(k) clearances on record.