510(k) K843253

EMG/NCV & EVOKED RESPONSE, DESIGN W/ by Neurodiagnostics, Inc. — Product Code GWF

K843253 is an FDA 510(k) premarket notification submitted by Neurodiagnostics, Inc. for the device "EMG/NCV & EVOKED RESPONSE, DESIGN W/". The FDA issued a decision of Substantially Equivalent on November 20, 1984. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Neurodiagnostics, Inc. has at least 3 other 510(k) clearances on record.