FDA Registration
Active
🇰🇷 South Korea
Oximeter (Models: Charmcare Tabletop Pulse Oximeter, ACCURO, CHARM II, CHARM III, CX130)
Reg #: 3006056594
·
FEI: 3006056594
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CHARMCARE CO., LTD
- Registration Number
- 3006056594
- FEI Number
- 3006056594
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 Gasan Digital 1-ro, Geumcheon-gu
- City
- Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K092641
Owner / Operator
- Firm Name
- CHARMCARE CO., LTD
- Operator Number
- 10062167
- Address
- Rm714, 2, Gasan digital 1-RO
- City
- Geumcheon-GU
- State
- Seoul
- Postal Code
- 08591
- Country
- KR
- Correspondent
- DongHwa Lee
US Agent
- Business Name
- Carrasco
- Contact Name
- Mateo Carrasco
- Address
- 1815 Barker Dr
- City
- Winter Park
- State
- FL
- ZIP
- 32789
- Country
- US
- [email protected]
- Phone
- 407 2849480
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-07-01 |
Proprietary Names
Oximeter (Models: Charmcare Tabletop Pulse Oximeter, ACCURO, CHARM II, CHARM III, CX130)
Establishment Types
Manufacture Medical Device