FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM

FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM is an FDA 510(k)-cleared medical device (K121341) 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 5, 2012. Regulation: 8.