CARDIAC OUTPUT COMPUTER (MODEL COC-100)

CARDIAC OUTPUT COMPUTER (MODEL COC-100) is an FDA 510(k)-cleared medical device (K760844) manufactured by B-D Electrodyne. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 1976. Regulation: 8.