ACCU-CHEK CONNECT DIABETES MANAGEMENT APP

ACCU-CHEK CONNECT DIABETES MANAGEMENT APP is an FDA 510(k)-cleared medical device (K141929) manufactured by Roche Diagnostics Corporation. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 2015. Regulation: 8.