PERFORMAX PEDIATRIC SE TOTAL FACE MASK

PERFORMAX PEDIATRIC SE TOTAL FACE MASK is an FDA 510(k)-cleared medical device (K120639) 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 July 9, 2012. Regulation: 8.