510(k) K083221

AIDERA DIASEND by Aidera AB — Product Code MRZ

K083221 is an FDA 510(k) premarket notification submitted by Aidera AB for the device "AIDERA DIASEND". The FDA issued a decision of Substantially Equivalent on February 3, 2009. 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.