ROKONICS SENTRY MODEL 8500

ROKONICS SENTRY MODEL 8500 is an FDA 510(k)-cleared medical device (K851819) manufactured by Rokonics, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 20, 1986. Regulation: 8.