510(k) K083124

NIM 3.0 by Medtronic Xomed, Inc. — Product Code GWF

K083124 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "NIM 3.0". The FDA issued a decision of Substantially Equivalent on February 27, 2009. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Medtronic Xomed, Inc. has at least 10 other 510(k) clearances on record.