FDA Registration
Active
🇩🇰 Denmark
GE OEC 9900 Elite
Reg #: 3009196578
·
FEI: 3009196578
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- LBN MEDICAL A/S
- Registration Number
- 3009196578
- FEI Number
- 3009196578
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gugvej 70
- City
- Aalborg Nordjylland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K122234
Owner / Operator
- Firm Name
- LBN Medical ApS
- Operator Number
- 10055731
- Address
- Gugvej 70
- City
- Aalborg
- State
- Nordjylland
- Postal Code
- 9210
- Country
- DK
- Correspondent
- Jesper K Nielsen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2022-01-03 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2022-01-03 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2022-01-03 |
Proprietary Names
GE OEC 9900 Elite
Establishment Types
Export Device to the United States But Perform No Other Operation on Device