510(k) K021742

GALEMED NEB-EASY NEBULIZER by Galemed Corp. — Product Code CAF

K021742 is an FDA 510(k) premarket notification submitted by Galemed Corp. for the device "GALEMED NEB-EASY NEBULIZER". The FDA issued a decision of Substantially Equivalent on October 25, 2002. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Galemed Corp. has at least 6 other 510(k) clearances on record.