FDA Registration
Active
🇮🇳 India
Premier 7000 CTL Spine coil
Reg #: 9613936
·
FEI: 1000571342
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WIPRO GE HEALTHCARE PRIVATE LTD
- Registration Number
- 9613936
- FEI Number
- 1000571342
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 122, Part I, EXPORT PROMOTIONAL INDUSTRIAL PARK
- City
- WHITEFIELD, BANGALORE Karnataka
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K980157
Owner / Operator
- Firm Name
- GE HealthCare Technologies Inc.
- Operator Number
- 9912004
- Address
- 3000 N. Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal Code
- 53188
- Country
- US
US Agent
- Business Name
- GE HealthCare Technologies, Inc
- Contact Name
- Tracey Holevas
- Address
- 3000 N. Grandview BLVD
- City
- Waukesha
- State
- WI
- ZIP
- 53188
- Country
- US
- [email protected]
- Phone
- 262 3092157
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2010-07-16 |
Proprietary Names
Premier 7000 CTL Spine coil
PHASED ARRAY-HDe
1.5T 4 Ch. Premier 7000 CTL Coil
1.5T, 4 CH. CTL SPINE COIL,
Signa HDe 1.5T 4CH CTL Spine Coil
Signa HD 1.5T CTL Spine Coil
Establishment Types
Manufacture Medical Device