510(k) K162873

MEP Monitor by Tonica Elektronik A/S — Product Code GWF

K162873 is an FDA 510(k) premarket notification submitted by Tonica Elektronik A/S for the device "MEP Monitor". The FDA issued a decision of Substantially Equivalent on March 31, 2017. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Tonica Elektronik A/S has at least 10 other 510(k) clearances on record.