510(k) DEN250002
- Device
- Delphi-MD System
- Applicant
- Quantalx Neuroscience, Ltd.
- 510(k) number
- DEN250002
- Product code
- SFN
- Decision
- Unknown (DENG)
- Decision date
- 2025-08-20
- Date received
- 2025-01-03
- Regulation
- 882.1860
- Classification name
- Non-Invasive Evoked Response Brain Stimulator
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Iftach Dolev
- Address
- 1 Hatachana Kfar Saba Kfar-Saba IL 4453001 4453001
FDA Registration Numbers
- 3020494684
- 3004016520
Source Documents
510(k) summary PDF not indicated by FDA