510(k) K242525

iTOF® by Nerbio Medical Software Platforms, Inc. — Product Code KOI

K242525 is an FDA 510(k) premarket notification submitted by Nerbio Medical Software Platforms, Inc. for the device "iTOF®". The FDA issued a decision of Substantially Equivalent on December 5, 2024. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775.