MODEL 105 VENTILATOR, MODIFICATION

MODEL 105 VENTILATOR, MODIFICATION is an FDA 510(k)-cleared medical device (K922477) 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 August 23, 1992. Regulation: 8.