HEALTHDYNE IMPLUSE VENTILATOR

HEALTHDYNE IMPLUSE VENTILATOR is an FDA 510(k)-cleared medical device (K853300) 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 August 14, 1985. Regulation: 8.