THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)

THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) is an FDA 510(k)-cleared medical device (K061328) manufactured by E-San Limited. 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 12, 2006. Regulation: 8.