INFRASONICS VENTILATOR ADULT STAR, MODIFICATION

INFRASONICS VENTILATOR ADULT STAR, MODIFICATION is an FDA 510(k)-cleared medical device (K911804) manufactured by Infrasonics Corp.. 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 10, 1992. Regulation: 8.