YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH

YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH is an FDA 510(k)-cleared medical device (K923894) manufactured by Biosound, 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 9, 1993. Regulation: 8.