510(k) K002543

COMOACT ULTRASONIC NEBULIZER, MODEL 3060 by San UP S.A. — Product Code CAF

K002543 is an FDA 510(k) premarket notification submitted by San UP S.A. for the device "COMOACT ULTRASONIC NEBULIZER, MODEL 3060". The FDA issued a decision of Substantially Equivalent on June 14, 2001. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. San UP S.A. has at least 1 other 510(k) clearance on record.