PART NO. 66-00121

PART NO. 66-00121 is an FDA 510(k)-cleared medical device (K770928) manufactured by Harlake Cyprane. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 1977. Regulation: 8.