I-NEB INSIGHT AAD SYSTEM

I-NEB INSIGHT AAD SYSTEM is an FDA 510(k)-cleared medical device (K052941) manufactured by Profile Therapeutics Plc. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 2005. Regulation: 8.