510(k) K243982

Nicolet EDX by Natus Neurology Incorporated — Product Code GWF

K243982 is an FDA 510(k) premarket notification submitted by Natus Neurology Incorporated for the device "Nicolet EDX". The FDA issued a decision of Substantially Equivalent on January 22, 2025. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Natus Neurology Incorporated has at least 4 other 510(k) clearances on record.