DEVILBISS SMARTLINK II SYSTEM

DEVILBISS SMARTLINK II SYSTEM is an FDA 510(k)-cleared medical device (K140880) manufactured by Devilbiss Healthcare, 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 August 3, 2014. Regulation: 8.