510(k) K050104

APEX MEDICAL MININEB & MINIPLUS by Apex Medical Corp. — Product Code CAF

K050104 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "APEX MEDICAL MININEB & MINIPLUS". The FDA issued a decision of Substantially Equivalent on February 16, 2005. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Apex Medical Corp. has at least 10 other 510(k) clearances on record.