MEDFUSION 2001 & 2010, MODEL N7215IWC

MEDFUSION 2001 & 2010, MODEL N7215IWC is an FDA 510(k)-cleared medical device (K012259) manufactured by National Custom Ent., Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 11, 2001. Regulation: 8.