DEVILBISS 9000 SERIES CPAP, MODEL 9001

DEVILBISS 9000 SERIES CPAP, MODEL 9001 is an FDA 510(k)-cleared medical device (K011229) manufactured by Sunrise Medical Hhg, 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 10, 2001. Regulation: 8.