E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER

E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER is an FDA 510(k)-cleared medical device (K042022) manufactured by Datrix, Inc. Dba of Jon Barron, 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 August 11, 2004. Regulation: 8.