NTU

Evoked Potential Stimulator, Thermal

Product code

NTU

Device name

Evoked Potential Stimulator, Thermal

Device class

Class 2

21 CFR

21 CFR 882.1870

Medical specialty

Neurology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

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

FDA classification definition

Intended to evaluate the functionality of human pain reception and transmission of sensory pathways

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