CAPNOCHECK II, MODEL 8400

CAPNOCHECK II, MODEL 8400 is an FDA 510(k)-cleared medical device (K991086) manufactured by Bci Intl., 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 June 8, 1999. Regulation: 8.