FDA product code SFN: Non-Invasive Evoked Response Brain Stimulator
SFN is the FDA product code for non-invasive evoked response brain stimulator. It is a Class II device, regulated under 21 CFR 882.1860 and reviewed by the Neurology panel. Devices under SFN reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Non-Invasive Evoked Response Brain Stimulator |
| Device class | Class II |
| Regulation | 21 CFR 882.1860 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for SFN devices
openFDA lists no recalls for product code SFN.
Frequently asked questions
What is FDA product code SFN?
SFN is the FDA product code for non-invasive evoked response brain stimulator. It is a Class II device, regulated under 21 CFR 882.1860 and reviewed by the Neurology panel.
What device class is SFN?
Class II, regulation 21 CFR 882.1860. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SFN
- Run a recall and safety report across every SFN manufacturer
- Watch product code SFN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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