510(k) K120397

MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM by Nihon Kohden Corp. — Product Code GWF

K120397 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corp. for the device "MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 19, 2012. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Nihon Kohden Corp. has at least 10 other 510(k) clearances on record.