EASY ECG PC BASED ELECTROCARDIOGRAPH

EASY ECG PC BASED ELECTROCARDIOGRAPH is an FDA 510(k)-cleared medical device (K972996) manufactured by Ates Medical S.R.L.. 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 27, 1998. Regulation: 8.