510(k) K111639

FRESENIUS 2008T HEMODIALYSIS MACHINE by Fresenius Medical Care — Product Code KDI

K111639 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care for the device "FRESENIUS 2008T HEMODIALYSIS MACHINE". The FDA issued a decision of Substantially Equivalent on October 21, 2011. 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 has at least 6 other 510(k) clearances on record.