De Novo DEN250013
- Device
- Modius Spero
- Contact
- jason mckeown
- De Novo number
- DEN250013
- Product code
- SHX
- Regulation
- 882.5807
- Classification name
- transcranial nerve stimulation device for the treatment of post-traumatic stress disorder associated symptoms
- Decision
- granted (DENG)
- Decision date
- 2026-05-08
- Date received
- 2025-04-16
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct