C.P.A.P. VALVE AND C.P.P.A. KIT

C.P.A.P. VALVE AND C.P.P.A. KIT is an FDA 510(k)-cleared medical device (K895360) manufactured by Ballard Medical Products. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 14, 1989. Regulation: 8.