510(k) K243495

Natus Ultrapro S100 (982A0594) by Natus Neurology Incorporated — Product Code GWF

K243495 is an FDA 510(k) premarket notification submitted by Natus Neurology Incorporated for the device "Natus Ultrapro S100 (982A0594)". The FDA issued a decision of Substantially Equivalent on December 12, 2024. 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.