HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM

HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM is an FDA 510(k)-cleared medical device (K073269) manufactured by Hypnocore, 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 April 17, 2008. Regulation: 8.