ACCU-CHEK Connect Diabetes Management App

ACCU-CHEK Connect Diabetes Management App is an FDA 510(k)-cleared medical device (K150910) manufactured by Roche Diabetes Care, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 2015. Regulation: 8.