CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR

CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR is an FDA 510(k)-cleared medical device (K122370) 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 September 25, 2013. Regulation: 8.