microTargeting Guideline 4000 5.0 System

microTargeting Guideline 4000 5.0 System is an FDA 510(k)-cleared medical device (K183123) manufactured by FHC, 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 December 19, 2018. Regulation: 8.