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Respironics, Inc.
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BIPAP PRO BI-LEVEL SYSTEM is an FDA 510(k)-cleared medical device (K011714) 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 June 27, 2001. Regulation: 8.