Simple T Pediatric Nasal Mask

Simple T Pediatric Nasal Mask is an FDA 510(k)-cleared medical device (K151120) manufactured by Respironics, Inc.. 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 14, 2016. Regulation: 8.