SFN

Non-Invasive Evoked Response Brain Stimulator

Product code

SFN

Device name

Non-Invasive Evoked Response Brain Stimulator

Device class

Class 2

21 CFR

21 CFR 882.1860

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

A non-invasive evoked response brain stimulator is a non-penetrating device used to apply a stimulus to the brain for the purpose of measuring the evoked brain activity response.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-08-20.