510(k) K992917

AEROCHAMBER PLUS VALVED HOLDING CHAMBER by Trudell Medical Int'L — Product Code CAF

K992917 is an FDA 510(k) premarket notification submitted by Trudell Medical Int'L for the device "AEROCHAMBER PLUS VALVED HOLDING CHAMBER". The FDA issued a decision of Substantially Equivalent on Sep 14, 1999. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Trudell Medical Int'L has 2 other 510(k) clearances on record.