510(k) K103635

CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S by Aerogen, Ltd. — Product Code CAF

K103635 is an FDA 510(k) premarket notification submitted by Aerogen, Ltd. for the device "CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S". The FDA issued a decision of Substantially Equivalent on May 13, 2011. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Aerogen, Ltd. has at least 8 other 510(k) clearances on record.