FDA Registration
Active
🇰🇷 South Korea
GE Discovery MR750
Reg #: 3026391023
·
FEI: 3026391023
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDICAPS CO., LTD
- Registration Number
- 3026391023
- FEI Number
- 3026391023
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5Fl., 10, Bundang-ro 53beon-gil, Bundang-gu,
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K160618
Owner / Operator
- Firm Name
- Medicaps Co., Ltd
- Operator Number
- 10092335
- Address
- 10, Bundang-ro 53beon-gil, Bundang-gu,
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13591
- Country
- KR
- Correspondent
- Kenny Kim
US Agent
- Business Name
- Block Imaging Parts and Service
- Contact Name
- Grace Lyon
- Address
- 1845 Cedar St
- City
- Holt
- State
- MI
- ZIP
- 48842
- Country
- US
- [email protected]
- Phone
- 517 6688800
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2025-06-20 |
Proprietary Names
GE Discovery MR750
Establishment Types
Export Device to the United States But Perform No Other Operation on Device