Product code SFN

Device name

Non-Invasive Evoked Response Brain Stimulator

Medical specialty

Neurology

Device class

2

Regulation number

882.1860

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset