510(k) DEN250002
DEN250002 is an FDA 510(k) premarket notification submitted by Quantalx Neuroscience, Ltd. for the device "Delphi-MD System". The FDA issued a decision of De Novo Granted on August 20, 2025. The device falls under product code SFN (Non-Invasive Evoked Response Brain Stimulator), a Class II device regulated under 21 CFR 882.1860. Quantalx Neuroscience, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 20, 2025
- Date Received
- January 3, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Invasive Evoked Response Brain Stimulator
- Device Class
- Class II
- Regulation Number
- 882.1860
- Review Panel
- NE
- Submission Type
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.