ACCU-CHEK LINKASSIST

ACCU-CHEK LINKASSIST is an FDA 510(k)-cleared medical device (K063146) 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 November 26, 2006. Regulation: 8.