510(k) K091457

NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM by Nexstim OY — Product Code GWF

K091457 is an FDA 510(k) premarket notification submitted by Nexstim OY for the device "NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 8, 2009. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Nexstim OY has at least 5 other 510(k) clearances on record.