De Novo DEN250002
- Device
- Delphi-MD System
- Contact
- iftach dolev
- De Novo number
- DEN250002
- Product code
- SFN
- Regulation
- 882.1860
- Classification name
- non-invasive evoked response brain stimulator
- Decision
- granted (DENG)
- Decision date
- 2025-08-20
- Date received
- 2025-01-03
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification
- Product code
- SFN
- Device name
- Non-Invasive Evoked Response Brain Stimulator
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.1860
- Implant
- N
- Life sustain/support
- N