AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE

AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE is an FDA 510(k)-cleared medical device (K032278) manufactured by Ambu, 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 4, 2004. Regulation: 8.