Positional Sleep Assessment System (PoSAS) software

Positional Sleep Assessment System (PoSAS) software is an FDA 510(k)-cleared medical device (K172799) manufactured by Advanced Brain Monitoring. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 8, 2018. Regulation: 8.