ELECTROCARDIOGRAPH, MODEL ECG-5151

ELECTROCARDIOGRAPH, MODEL ECG-5151 is an FDA 510(k)-cleared medical device (K792229) 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 November 20, 1979. Regulation: 8.