SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504

SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 is an FDA 510(k)-cleared medical device (K982225) manufactured by Spiracle Technology. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 27, 1998. Regulation: 8.