FDA Registration
Active
🇨🇳 China
Arm Electronic Sphygmomanometer /Arm Blood Pressure Monitor, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-A156
Reg #: 3009617411
·
FEI: 3009617411
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
- Registration Number
- 3009617411
- FEI Number
- 3009617411
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 101, Building 1, No.15 Xiusheng 2nd Road, Xiuxin Community, Kengzi Street, Pingshan District,
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K193387
Owner / Operator
- Firm Name
- Shenzhen Changkun Technology Co., Ltd.
- Operator Number
- 10071297
- Address
- 101, Building 1, No.15 Xiusheng 2nd Road, Xiuxin Community, Kengzi Street, Pingshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518118
- Country
- CN
- Correspondent
- Qingpeng Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2021-03-29 |
Proprietary Names
Arm Electronic Sphygmomanometer /Arm Blood Pressure Monitor, Models: CK-A120,CK-A136,CK-A138,CK-A139,CK-A155,CK-A156
Arm Electronic Sphygmomanometer/Arm Blood Pressure Monitor, Models: CK-A159, CK-A1912, CK-A1915, CK-A1915P, CK-A1916
Arm Electronic Sphygmomanometer/Arm Blood Pressure Monitor, Models:CK-A1916P, CK-A2006, CK-A2008, X180, CK-A158, CK-A168
Establishment Types
Manufacture Medical Device