CARDIOFAX ECG-6353

CARDIOFAX ECG-6353 is an FDA 510(k)-cleared medical device (K860212) 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, 1986. Regulation: 8.