510(k) K160280

MagPro R20 by Tonica Elektronik A/S — Product Code GWF

K160280 is an FDA 510(k) premarket notification submitted by Tonica Elektronik A/S for the device "MagPro R20". The FDA issued a decision of Substantially Equivalent on May 16, 2016. 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.