CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR

CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR is an FDA 510(k)-cleared medical device (K071911) manufactured by Innovision A/S. 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 6, 2007. Regulation: 8.