510(k) K053605

AEROECLIPSE II BREATH ACTUATED NEBULIZER by Trudell Medical Intl. — Product Code CAF

K053605 is an FDA 510(k) premarket notification submitted by Trudell Medical Intl. for the device "AEROECLIPSE II BREATH ACTUATED NEBULIZER". The FDA issued a decision of Substantially Equivalent on February 27, 2006. 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.