510(k) K992831

AERONEB II, MODEL APN 200 by Aerogen, Inc. — Product Code CAF

K992831 is an FDA 510(k) premarket notification submitted by Aerogen, Inc. for the device "AERONEB II, MODEL APN 200". The FDA issued a decision of Substantially Equivalent on August 25, 2000. 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.