FRESENIUS OPTIFLUX 200NR

FRESENIUS OPTIFLUX 200NR is an FDA 510(k)-cleared medical device (K002277) manufactured by Fresenius Medical Care North America. 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 August 24, 2000. Regulation: 8.