510(k) K021175

AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 by Aerogen, Inc. — Product Code CAF

K021175 is an FDA 510(k) premarket notification submitted by Aerogen, Inc. for the device "AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000". The FDA issued a decision of Substantially Equivalent on May 15, 2002. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Aerogen, Inc. has at least 8 other 510(k) clearances on record.