iCE-SG Subcutaneous Electrode Arrays

iCE-SG Subcutaneous Electrode Arrays is an FDA 510(k)-cleared medical device (K201678) manufactured by Ice Neurosystems, 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 March 7, 2021. Regulation: 8.