510(k) K203062

Optiflux Series of Dialyzers F160NR, F180NR, F200NR by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KDI

K203062 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "Optiflux Series of Dialyzers F160NR, F180NR, F200NR". The FDA issued a decision of Substantially Equivalent on Dec 28, 2020. 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 Renal Therapies Group, LLC has 51 other 510(k) clearances on record.