FDA Registration
Active
🇺🇸 United States
EnVisio Surgical Navigation
Reg #: 2135401
·
FEI: 3003367650
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EI MICROCIRCUITS
- Registration Number
- 2135401
- FEI Number
- 3003367650
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 69 Power Dr
- City
- Mankato
- State
- MN
- ZIP
- 56001
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183400
Owner / Operator
- Firm Name
- EI Microcircuits, Inc.
- Operator Number
- 10043468
- Address
- 69 Power Drive
- City
- Mankato
- State
- MN
- Postal Code
- 56001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2021-12-08 |
Proprietary Names
EnVisio Surgical Navigation
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)