MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System

MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System is an FDA 510(k)-cleared medical device (K160064) manufactured by Infobionic, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 2016. Regulation: 8.