2008K@HOME HEMODIALYSIS MACHINE

2008K@HOME HEMODIALYSIS MACHINE is an FDA 510(k)-cleared medical device (K124035) 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 July 2, 2013. Regulation: 8.