VPAP AUTO WITH HUMIDAIRE 3I

VPAP AUTO WITH HUMIDAIRE 3I is an FDA 510(k)-cleared medical device (K082605) manufactured by Resmed, Ltd.. 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 12, 2009. Regulation: 8.