FDA Registration
Active
🇺🇸 United States
OEC 9900 Elite
Reg #: 1720753
·
FEI: 1720753
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- GE OEC MEDICAL SYSTEMS, INC
- Registration Number
- 1720753
- FEI Number
- 1720753
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 384 N WRIGHT BROTHERS DR
- City
- SALT LAKE CITY
- State
- UT
- ZIP
- 84116
- Country
- US
Regulatory Submissions
- 510(k) Number
- K082781
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2009-09-03 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2009-09-03 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2009-09-03 |
Proprietary Names
OEC 9900 Elite
Establishment Types
Manufacture Medical Device