ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM

ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM is an FDA 510(k)-cleared medical device (K974200) manufactured by Orca Diagnostics Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 20, 1998. Regulation: 8.