FRESENIUS ULTRAFLO HPX HEMODIALYZER

FRESENIUS ULTRAFLO HPX HEMODIALYZER is an FDA 510(k)-cleared medical device (K034064) 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 January 29, 2004. Regulation: 8.