SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER

SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER is an FDA 510(k)-cleared medical device (K841401) 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 January 13, 1985. Regulation: 8.