
Endocardial Solutions, Inc.
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MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 is an FDA 510(k)-cleared medical device (K030129) 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 April 21, 2003. Regulation: 8.