RESPIRONICS' REMSTAR(TM) SLEEPEASY

RESPIRONICS' REMSTAR(TM) SLEEPEASY is an FDA 510(k)-cleared medical device (K900113) manufactured by Respironics, 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 March 27, 1990. Regulation: 8.