DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST

DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST is an FDA 510(k)-cleared medical device (K091919) manufactured by Sunrise Medical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 27, 2009. Regulation: 8.