FDA Registration
Active
🇨🇳 China
YK-80A,YK-80B,YK-80C,YK-84A,YK-84B,YK-84C -Fingertip Pulse Oximeter
Reg #: 3017406171
·
FEI: 3017406171
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
- Registration Number
- 3017406171
- FEI Number
- 3017406171
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1st&2nd Floor,6#01,6#02,No.6 Building 1st Phase Economic Development Manufacturing Zone, LIANDO U Valley, No.6 Leye Road,Xuzhou ETDZ
- City
- Xuzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K161938
Owner / Operator
- Firm Name
- Xuzhou Yongkang Electronic Science Technology Co., Ltd
- Operator Number
- 10054941
- Address
- 1st&2nd Floor,6#01,6#02,No.6 Building 1st Phase Economic Development Manufacturing Zone, LIANDO U Valley, No.6, Leye Road ,Xuzhou ETDZ,221000 Xuzhou,PEOPLE'S REPUBLIC OF CHINA
- City
- xuzhou
- State
- Jiangsu
- Postal Code
- 221000
- Country
- CN
- Correspondent
- Pei Yu
US Agent
- Business Name
- ZYPPEL LLC
- Contact Name
- Qihui Zhang
- Address
- 1337 Mass Ave Pmb 158
- City
- Arlington
- State
- MA
- ZIP
- 02476
- Country
- US
- [email protected]
- Phone
- 617 2991655
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2017-05-16 |
Proprietary Names
YK-80A,YK-80B,YK-80C,YK-84A,YK-84B,YK-84C -Fingertip Pulse Oximeter
YK-81A,YK-81B,YK-81C,YK-82A,YK-82B,YK-82C,YK-83A,YK-83B,YK-83C-Fingertip Pulse Oximeter
BPX800US-Fingertip Pulse Oximeter
BPX801US-Fingertip Pulse Oximeter
Establishment Types
Manufacture Medical Device