CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM

CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K121087) 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 June 27, 2012. Regulation: 8.