ENSTYLET MODELS EC0010, EC0020

ENSTYLET MODELS EC0010, EC0020 is an FDA 510(k)-cleared medical device (K993376) 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 January 4, 2000. Regulation: 8.