THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2

THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 is an FDA 510(k)-cleared medical device (K872529) manufactured by American Edwards Laboratories. 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 14, 1987. Regulation: 8.