SMART USBLITE, MODEL M011120

SMART USBLITE, MODEL M011120 is an FDA 510(k)-cleared medical device (K061443) manufactured by Intelligent Hearing Systems. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 22, 2006. Regulation: 8.