510(k) K061645

MAGPRO, MODEL R30 by Tonica Elektronik A/S — Product Code GWF

K061645 is an FDA 510(k) premarket notification submitted by Tonica Elektronik A/S for the device "MAGPRO, MODEL R30". The FDA issued a decision of Substantially Equivalent on October 31, 2006. 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.