DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System

DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System is an FDA 510(k)-cleared medical device (K142344) manufactured by Izi Medical Products, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 2015. Regulation: 8.