
Respironics, Inc.
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BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK is an FDA 510(k)-cleared medical device (K101130) 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 September 1, 2010. Regulation: 8.