510(k) K070990

APEX MEDICAL MOBINEB, 9R-027 SERIES by Apex Medical Corp. — Product Code CAF

K070990 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "APEX MEDICAL MOBINEB, 9R-027 SERIES". The FDA issued a decision of Substantially Equivalent on May 18, 2007. 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.