FDA Registration
Active
🇨🇳 China
MAGNETOM Combi Suite Neurosurgery for MAGNETOM systems Aera and Skyra.
Reg #: 3004754211
·
FEI: 3004754211
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
- Registration Number
- 3004754211
- FEI Number
- 3004754211
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SIEMEN MRI CENTER, Gaoxin C.Ave.,2nd, Hi-Tech Industrial Park
- City
- SHENZHEN Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K142515
Owner / Operator
- Firm Name
- Siemens Healthineers AG
- Operator Number
- 8010024
- Address
- Karlheinz-Kaske-Str. 5, --
- City
- Erlangen
- State
- DE-NOTA
- Postal Code
- 91052
- Country
- DE
US Agent
- Business Name
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Contact Name
- Robert Phillips
- Address
- 40 Liberty Boulevard
- City
- MALVERN
- State
- PA
- ZIP
- 19355
- Country
- US
- [email protected]
- Phone
- 302 2359839
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2014-11-07 |
Proprietary Names
MAGNETOM Combi Suite Neurosurgery for MAGNETOM systems Aera and Skyra.
Establishment Types
Manufacture Medical Device