LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE

LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE is an FDA 510(k)-cleared medical device (K130657) manufactured by All Medicus Co., Ltd.. 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 July 14, 2013. Regulation: 8.