BREATHEX OMEGA CPAP DEVICE, MODEL 322

BREATHEX OMEGA CPAP DEVICE, MODEL 322 is an FDA 510(k)-cleared medical device (K052597) 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 December 15, 2005. Regulation: 8.