FDA Registration
Active
🇨🇦 Canada
Acuson S2000 Diagnostic Ultrasound System
Reg #: 3012127758
·
FEI: 3012127758
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Siemens Healthcare Limited
- Registration Number
- 3012127758
- FEI Number
- 3012127758
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1577 North Service Road East
- City
- Oakville Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K142876
Owner / Operator
- Firm Name
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Operator Number
- 9002915
- Address
- 40 Liberty Boulevard
- City
- Malvern
- State
- PA
- Postal Code
- 19355
- Country
- US
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 6319702
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2014-11-04 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2014-11-04 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2014-11-04 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2014-11-04 |
Proprietary Names
Acuson S2000 Diagnostic Ultrasound System
Acuson S1000 Diagnostic Ultrasound System
Acuson S3000 Diagnostic Ultrasound System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device