ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH

ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH is an FDA 510(k)-cleared medical device (K032200) manufactured by Remco Italia S.P.A.. 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 2, 2003. Regulation: 8.