FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR

FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR is an FDA 510(k)-cleared medical device (K043244) 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 December 19, 2004. Regulation: 8.