BIO-DETEK EEG ELECTRODE

BIO-DETEK EEG ELECTRODE is an FDA 510(k)-cleared medical device (K920352) manufactured by Bio-Detek, 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 August 13, 1992. Regulation: 8.