BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003

BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 is an FDA 510(k)-cleared medical device (K061099) manufactured by Hoffman Laboratories, 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 August 10, 2006. Regulation: 8.