CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC

CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC is an FDA 510(k)-cleared medical device (K844116) manufactured by Critikon Company, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 27, 1985. Regulation: 8.