CARDIOFAX-V ECG-8240A

CARDIOFAX-V ECG-8240A is an FDA 510(k)-cleared medical device (K865030) 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 March 9, 1987. Regulation: 8.