GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION

GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION is an FDA 510(k)-cleared medical device (K131230) manufactured by Philosys, Inc.. 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 August 3, 2014. Regulation: 8.