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
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.