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Sleepnet Corporation
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IQ NASAL MASK, MODEL 50160 REV. D is an FDA 510(k)-cleared medical device (K021534) 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 July 1, 2002. Regulation: 8.