REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM

REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM is an FDA 510(k)-cleared medical device (K090243) manufactured by Respironics Inc., Sleep & Home Respiratory Group. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 7, 2009. Regulation: 8.