RESPIRONICS BIPAP REMOTE CONTROL UNIT

RESPIRONICS BIPAP REMOTE CONTROL UNIT is an FDA 510(k)-cleared medical device (K905540) 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 January 29, 1991. Regulation: 8.