CARDIOFAX ECG 6543

CARDIOFAX ECG 6543 is an FDA 510(k)-cleared medical device (K840274) manufactured by Nihon Kohden America, 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 16, 1984. Regulation: 8.