MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS

MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS is an FDA 510(k)-cleared medical device (K081703) manufactured by Entra Health Systems, 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 January 7, 2009. Regulation: 8.