PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM

PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM is an FDA 510(k)-cleared medical device (K935784) manufactured by Puritan-Bennett. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 12, 1994. Regulation: 8.