SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT

SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT is an FDA 510(k)-cleared medical device (K945407) manufactured by Mallinckrodt Medical Tpi, 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 February 26, 1995. Regulation: 8.