Non-Invasive Evoked Response Brain Stimulator

SFN · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1860

Classification

FDA Product Code: SFN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.1860
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown