SLEEPWEAVER NASAL CPAP MASK

SLEEPWEAVER NASAL CPAP MASK is an FDA 510(k)-cleared medical device (K092362) 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 November 1, 2009. Regulation: 8.