COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13

COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13 is an FDA 510(k)-cleared medical device (K823585) manufactured by Brentwood Instruments, 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 5, 1983. Regulation: 8.