BIPAP A 30 VENTILATORY SUPPORT SYSTEM

BIPAP A 30 VENTILATORY SUPPORT SYSTEM is an FDA 510(k)-cleared medical device (K113053) 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 31, 2012. Regulation: 8.