DEN250002 is an FDA 510(k) submission for the Delphi-MD System. This device is classified as a Non-invasive Evoked Response Brain Stimulator (Class II - Special Controls, product code SFN).
Submitted by Quantalx Neuroscience, Ltd. (Kfar-Saba, IL). The FDA issued a Not Cleared (DENG) decision on August 20, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1860. 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..
| 510(k) Number | DEN250002 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | January 03, 2025 |
| Decision Date | August 20, 2025 |
| Days to Decision | 229 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | SFN - Non-invasive Evoked Response Brain Stimulator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1860 |
| 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. |