510(k) K121341

FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM by Fresenius Medical Care North America — Product Code KDI

K121341 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM". The FDA issued a decision of Substantially Equivalent on December 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 has at least 10 other 510(k) clearances on record.