SFN · Class II · 21 CFR 882.1860

FDA Product Code SFN: Non-invasive Evoked Response Brain Stimulator

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.

Leading manufacturers include Quantalx Neuroscience, Ltd..

1
Total
0
Cleared
229d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Non-invasive Evoked Response Brain Stimulator Devices (Product Code SFN)

1 devices
1–1 of 1
Not Cleared Aug 20, 2025
Delphi-MD System
DEN250002
Quantalx Neuroscience, Ltd.
Neurology · 229d

About Product Code SFN - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SFN since 2025, with 0 receiving FDA clearance (average review time: 229 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SFN devices are reviewed by the Neurology panel. Browse all Neurology devices →