FDA 510(k)
FDA class 2
Unknown
🇬🇧 United Kingdom
Modius Spero
K Number: DEN250013
·
Decision May 8, 2026
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
3
Review Days
387
Basic Information
- Device Name
- Modius Spero
- K Number
- DEN250013
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.5807
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Neurovalens Limited
- Date Received
- April 16, 2025
- Decision Date
- May 8, 2026
- Product Code
- SHX
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SHX | Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms | FDA class 2 | Neurology |