SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X

SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X is an FDA 510(k)-cleared medical device (K063288) manufactured by Cardinal Health 303,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 November 27, 2006. Regulation: 8.