FDA Registration
Active
🇰🇷 South Korea
SwiftMR
Reg #: 3024820186
·
FEI: 3024820186
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AIRS Medical Inc.
- Registration Number
- 3024820186
- FEI Number
- 3024820186
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 13-14F, Keungil Tower, 223, Teheran-ro, Gangnam-gu
- City
- Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K210999
Owner / Operator
- Firm Name
- AIRS Medical Inc.
- Operator Number
- 10086333
- Address
- 475 North Martingale Rd, Suite 710
- City
- Schaumburg
- State
- IL
- Postal Code
- 60173
- Country
- US
- Correspondent
- Markus Cho
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2022-11-02 |
Proprietary Names
SwiftMR
Establishment Types
Manufacture Medical Device