510(k) DEN250013
- Device
- Modius Spero
- Applicant
- Neurovalens Limited
- 510(k) number
- DEN250013
- Product code
- SHX
- Decision
- Unknown (DENG)
- Decision date
- 2026-05-08
- Date received
- 2025-04-16
- Review panel
- Unknown
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jason Mckeown
- Address
- 8 Carmagrim Rd. Portglenone GB BT44 8BP BT44 8BP
Source Documents#
510(k) summary PDF not indicated by FDA