FDA Registration
Active
🇺🇸 United States
InterX5000 Flexible Array Electrode
Reg #: 3005698910
·
FEI: 3005698910
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SVTRONICS, INC.
- Registration Number
- 3005698910
- FEI Number
- 3005698910
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3465 Technology Dr
- City
- Plano
- State
- TX
- ZIP
- 75074
- Country
- US
Regulatory Submissions
- 510(k) Number
- K053626
Owner / Operator
- Firm Name
- SVTronics, Inc.
- Operator Number
- 10091965
- Address
- 3465 Technology Drive
- City
- Plano
- State
- TX
- Postal Code
- 75074
- Country
- US
- Correspondent
- Jasmat Sutaria
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2024-11-20 |
Proprietary Names
InterX5000 Flexible Array Electrode
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)