510(k) K083158

EXALIS, SOFTWARE VERSION 1.15 by Gambro, Inc. — Product Code KDI

K083158 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "EXALIS, SOFTWARE VERSION 1.15". The FDA issued a decision of Substantially Equivalent on June 5, 2009. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Gambro, Inc. has at least 10 other 510(k) clearances on record.