DEN250002
- 510(k) number
- DEN250002
- Device name
- Delphi-MD System
- Applicant
- Quantalx Neuroscience, Ltd. IL
- Product code
- SFN — Non-Invasive Evoked Response Brain Stimulator
- Decision date
- 2025-08-20
- Date received
- 2025-01-03
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Neurology
Official FDA record: DEN250002
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.