SleepWeaver Advance Pediatric Nasal CPAP Mask

SleepWeaver Advance Pediatric Nasal CPAP Mask is an FDA 510(k)-cleared medical device (K151683) 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 4, 2016. Regulation: 8.