Ventilator, Non-continuous (Respirator)

Ventilator, Non-continuous (Respirator) is an FDA 510(k)-cleared medical device (K201439) manufactured by Respironics, 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 24, 2020. Regulation: 8.