GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.

GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT. is an FDA 510(k)-cleared medical device (K911989) manufactured by Somnitec, 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 July 29, 1991. Regulation: 8.