INTERACOUSTICS EP 15 ABR STAND ALONE UNIT

INTERACOUSTICS EP 15 ABR STAND ALONE UNIT is an FDA 510(k)-cleared medical device (K991853) manufactured by Idem (Int'L Dist. of Electronics For Medicine). This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 1999. Regulation: 8.