FDA Registration
Active
🇹🇼 Taiwan
SpO2 Cable
Reg #: 3009139884
·
FEI: 3009139884
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SINBON ELECTRONICS CO., LTD
- Registration Number
- 3009139884
- FEI Number
- 3009139884
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 582 Kuohwa Rd., Miaoli 360, Taiwan
- City
- Miaoli
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K201179
Owner / Operator
- Firm Name
- SINBON ELECTRONICS CO., LTD
- Operator Number
- 10070964
- Address
- 582 Kuohwa Rd., Miaoli 360, Taiwan
- City
- Miaoli
- State
- TW-MIA
- Postal Code
- 360
- Country
- TW
- Correspondent
- Allison Yang
US Agent
- Business Name
- SINBON USA LLC
- Contact Name
- Winnie Chen
- Address
- 4265 GIBSON DR.TIPP CITY
- City
- Tipp City
- State
- OH
- ZIP
- 45371
- Country
- US
- [email protected]
- Phone
- 931 2208988
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-08-11 |
Proprietary Names
SpO2 Cable
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)