
Hypnocore, Ltd.
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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.