Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 is an FDA 510(k)-cleared medical device (K160187) manufactured by St Jude Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 20, 2016. Regulation: 8.