FDA Registration
Active
🇫🇷 France
Sonio Detect v2
Reg #: 3029937167
·
FEI: 3029937167
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- SONIO
- Registration Number
- 3029937167
- FEI Number
- 3029937167
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 147 rue d'Aboukir
- City
- Paris
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K240406
Owner / Operator
- Firm Name
- Sonio
- Operator Number
- 10088709
- Address
- 147 rue d'Aboukir
- City
- Paris
- State
- FR-75
- Postal Code
- 75002
- Country
- FR
- Correspondent
- Florian Akpakpa
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2025-01-08 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-01-08 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2025-01-08 |
Proprietary Names
Sonio Detect v2
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device