BRAIN FUNCTION MAPPING OPTION FOR PATHF

BRAIN FUNCTION MAPPING OPTION FOR PATHF is an FDA 510(k)-cleared medical device (K843598) manufactured by Nicolet Biomedical Instruments. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 10, 1985. Regulation: 8.