MADSEN ACCUSCREEN TYPE 1077

MADSEN ACCUSCREEN TYPE 1077 is an FDA 510(k)-cleared medical device (K132957) manufactured by Gn Otometrics. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 2014. Regulation: 8.