StealthStationTM S8 ENT Software

StealthStationTM S8 ENT Software is an FDA 510(k)-cleared medical device (K170018) manufactured by Medtronic Navigation, 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 May 18, 2017. Regulation: 8.