INFANT VENTILATOR, (RESPIRATOR) PLAN B

INFANT VENTILATOR, (RESPIRATOR) PLAN B is an FDA 510(k)-cleared medical device (K802583) 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 December 17, 1980. Regulation: 8.