CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER

CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER is an FDA 510(k)-cleared medical device (K110894) manufactured by Bayer Healthcare. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 27, 2012. Regulation: 8.