510(k) K192707

Optiflux F180NR Dialyzer by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KDI

K192707 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "Optiflux F180NR Dialyzer". The FDA issued a decision of Substantially Equivalent on Sep 21, 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.