ELI 280 ELECTROCARDIOGRAPH

ELI 280 ELECTROCARDIOGRAPH is an FDA 510(k)-cleared medical device (K122073) manufactured by Mortara Instrument, 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 1, 2012. Regulation: 8.