RONDEX MASKS MODELS 9015/9011/901102 MODIFIED

RONDEX MASKS MODELS 9015/9011/901102 MODIFIED is an FDA 510(k)-cleared medical device (K914196) manufactured by Rondex Products, 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 November 7, 1991. Regulation: 8.