PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)

PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) is an FDA 510(k)-cleared medical device (K950331) manufactured by Healthdyne, 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 September 20, 1995. Regulation: 8.