510(k) K101715

FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 by Fresenius Medical Care North America, Design Cente — Product Code KDI

K101715 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America, Design Cente for the device "FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573". The FDA issued a decision of Substantially Equivalent on December 21, 2010. 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. Fresenius Medical Care North America, Design Cente has at least 4 other 510(k) clearances on record.