510(k) K120505

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

K120505 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America, Design Cente for the device "FRESENIUS 2008T HEMODIALYSIS MACHINE". The FDA issued a decision of Substantially Equivalent on March 6, 2012. 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.