
Respironics, Inc.
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RESPIRONICS SLEEPEASY CPAP SYSTEM is an FDA 510(k)-cleared medical device (K091112) 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 May 14, 2009. Regulation: 8.