510(k) K071821

COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 by Tonica Elektronik A/S — Product Code GWF

K071821 is an FDA 510(k) premarket notification submitted by Tonica Elektronik A/S for the device "COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65". The FDA issued a decision of Substantially Equivalent on July 27, 2007. 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.