THE IMS DPAP MASK, IMS MODEL NUMBER 82000

THE IMS DPAP MASK, IMS MODEL NUMBER 82000 is an FDA 510(k)-cleared medical device (K953697) manufactured by Sleepnet Corporation. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 1996. Regulation: 8.