EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE

EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE is an FDA 510(k)-cleared medical device (K093715) manufactured by Magnatone Hearing Aid Corp. Dba Persona Medical. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2010. Regulation: 8.