Puritan Bennett 980 Ventilator System

Puritan Bennett 980 Ventilator System is an FDA 510(k)-cleared medical device (K162738) manufactured by Covidien. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2017. Regulation: 8.