Polysmith Sleep System, Model NTI7593

Polysmith Sleep System, Model NTI7593 is an FDA 510(k)-cleared medical device (K161650) manufactured by Neurotronics, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 18, 2017. Regulation: 8.