AMBIO REMOTE HEALTH MONITORING SYSTEM

AMBIO REMOTE HEALTH MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K130676) manufactured by Arrayent Health, LLC D/B/A Ambio Health. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 7, 2013. Regulation: 8.