CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)

CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH) is an FDA 510(k)-cleared medical device (K863116) 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 September 16, 1986. Regulation: 8.