FDA Registration
Active
🇸🇰 Slovakia
ACUSON Juniper Diagnostic Ultrasound System
Reg #: 3014745562
·
FEI: 3014745562
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Siemens Healthcare s.r.o.
- Registration Number
- 3014745562
- FEI Number
- 3014745562
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Panattoni Park Kosice Airport, ul. Andreja Kvasa 5
- City
- Kosice-Barca Kosicky
- Country
- SK
Regulatory Submissions
- 510(k) Number
- K221190
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
- Zhengbin Xu
- Address
- 22010 SE 51 Street
- City
- Issaquah
- State
- WA
- ZIP
- 98029
- Country
- US
- [email protected]
- Phone
- 425 2418272
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2022-08-22 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2022-08-22 |
| Biopsy Needle Guide Kit | OIJ | Class 2 | Radiology | No | 2022-08-22 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2022-08-22 |
Proprietary Names
ACUSON Juniper Diagnostic Ultrasound System
ACUSON Juniper Select Diagnostic Ultrasound System
Establishment Types
Manufacture Medical Device