510(k) K101806

AIDERA DIASEND SYSTEM by Aidera AB — Product Code MRZ

K101806 is an FDA 510(k) premarket notification submitted by Aidera AB for the device "AIDERA DIASEND SYSTEM". The FDA issued a decision of Substantially Equivalent on December 7, 2010. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Aidera AB has at least 1 other 510(k) clearance on record.