Optiflux F180NR Dialyzer

Optiflux F180NR Dialyzer is an FDA 510(k)-cleared medical device (K192707) manufactured by Fresenius Medical Care Renal Therapies Group, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 20, 2020. Regulation: 8.