DEN250013
- 510(k) number
- DEN250013
- Device name
- Modius Spero
- Applicant
- Neurovalens Limited GB
- Product code
- SHX — Transcranial Nerve Stimulation Device For The Treatm
- Decision date
- 2026-05-08
- Date received
- 2025-04-16
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Neurology
Official FDA record: DEN250013
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.