FUKUDA DENSHI MODEL SPIROSIFT SP-5000

FUKUDA DENSHI MODEL SPIROSIFT SP-5000 is an FDA 510(k)-cleared medical device (K922428) 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 January 14, 1993. Regulation: 8.