FDA Registration
Active
🇩🇰 Denmark
Siemens EC9-4W for X600/X700
Reg #: 3009196578
·
FEI: 3009196578
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
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
- K141846
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, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2018-05-16 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2018-05-16 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2018-05-16 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2018-05-16 |
Proprietary Names
Siemens EC9-4W for X600/X700
Siemens Probe VF12-4 for X700
Siemens EC9-4
Establishment Types
Export Device to the United States But Perform No Other Operation on Device