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Circadiance, LLC
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SLEEPWEAVER ELAN NASAL CPAP MASK is an FDA 510(k)-cleared medical device (K120757) manufactured by Circadiance, LLC. 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 23, 2012. Regulation: 8.