BIPAP HARMONY S/T, MODEL 1001445

BIPAP HARMONY S/T, MODEL 1001445 is an FDA 510(k)-cleared medical device (K984407) 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 18, 1999. Regulation: 8.