
Respironics, Inc.
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BIPAP PLUS M-SERIES BI-LEVEL SYSTEM is an FDA 510(k)-cleared medical device (K061034) 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 22, 2006. Regulation: 8.