510(k) K090065

AEROCHAMBER MINI VENTILATION CHAMBER by Trudell Medical Intl. — Product Code CAF

K090065 is an FDA 510(k) premarket notification submitted by Trudell Medical Intl. for the device "AEROCHAMBER MINI VENTILATION CHAMBER". The FDA issued a decision of Substantially Equivalent on April 9, 2009. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Trudell Medical Intl. has at least 10 other 510(k) clearances on record.