SFN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Non-Invasive Evoked Response Brain Stimulator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1860
- Medical specialty
- Neurology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Delphi-MD System (DEN250002) | Quantalx Neuroscience, Ltd. | 2025-08-20 |
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