Puritan Bennett 980 Series Ventilator System

Puritan Bennett 980 Series Ventilator System is an FDA 510(k)-cleared medical device (K193056) manufactured by Covidien, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 2020. Regulation: 8.