DEMAND FLOW VALVE & SONRA W/NASAL MASK

DEMAND FLOW VALVE & SONRA W/NASAL MASK is an FDA 510(k)-cleared medical device (K854571) manufactured by Gale E. Dryden. 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 9, 1986. Regulation: 8.