510(k) K032741

EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION by Axon Systems, Inc. — Product Code GWF

K032741 is an FDA 510(k) premarket notification submitted by Axon Systems, Inc. for the device "EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION". The FDA issued a decision of Substantially Equivalent on December 16, 2003. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Axon Systems, Inc. has at least 10 other 510(k) clearances on record.