CARDIAC COMPUTERS, CO-10 & CO-10R

CARDIAC COMPUTERS, CO-10 & CO-10R is an FDA 510(k)-cleared medical device (K781805) manufactured by Waters Assoc., 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 January 28, 1979. Regulation: 8.