CARDIO-DATA SYSTEM, #MARK III

CARDIO-DATA SYSTEM, #MARK III is an FDA 510(k)-cleared medical device (K812149) manufactured by Cardio Data. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 1981. Regulation: 8.