FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE

FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE is an FDA 510(k)-cleared medical device (K980979) manufactured by Fukuda Denshi USA, 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 11, 1998. Regulation: 8.