ENSITE 3000 SYSTEM, MODEL EE3000

ENSITE 3000 SYSTEM, MODEL EE3000 is an FDA 510(k)-cleared medical device (K001437) manufactured by Endocardial Solutions, 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 June 6, 2000. Regulation: 8.