ACCU-CHEK ULTRAFLEX INFUSION SET

ACCU-CHEK ULTRAFLEX INFUSION SET is an FDA 510(k)-cleared medical device (K070189) manufactured by Disetronic Medical Systems AG. 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 February 20, 2007. Regulation: 8.