ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM

ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM is an FDA 510(k)-cleared medical device (K080227) manufactured by Roche Diagnostics Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 14, 2008. Regulation: 8.