PAIRED HYDROGEL ELECTRODE

PAIRED HYDROGEL ELECTRODE is an FDA 510(k)-cleared medical device (K110138) manufactured by Neurovision Medical Products, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 7, 2011. Regulation: 8.