SFN — Non-Invasive Evoked Response Brain Stimulator Class II
FDA product code SFN covers "Non-Invasive Evoked Response Brain Stimulator", a Class II medical device regulated under 21 CFR 882.1860. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SFN
- Device Class
- Class II
- Regulation Number
- 882.1860
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250002 | quantalx neuroscience | Delphi-MD System | August 20, 2025 |