NIHON KOHDEN ELECTROCARDIOGRAPH

NIHON KOHDEN ELECTROCARDIOGRAPH is an FDA 510(k)-cleared medical device (K813266) 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 January 28, 1982. Regulation: 8.