Data / Medical devices / China / Shenzhen Zhengkang Technology Co., Ltd.
Shenzhen Zhengkang Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Shenzhen Zhengkang Technology Co., Ltd. is registered with the FDA (registration 3015697152) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 16, 2022. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015697152
- Address
- 2&3/F,Building A, No.3 FuXing Yi Lane, HeHua Community PingHu Street, LongGang District, Shenzhen Guangdong, China, 518100
- Owner or operator
- ShenZhen ZhengKang Technology Co., Ltd. (10062909)
- Roles
- Manufacturer
- First device listed
- March 13, 2020
- Registered through
- 2026
- Brand names listed
- Infrared Forehead Thermometer, Oximeter, Upper Arm Blood Pressure Monitor, Models: ZK-B868, ZK-B869, ZK-B872,ZK-B876, Upper Arm Blood Pressure Monitor, Models: ZK-B881, ZK-B882, ZK-B883, ZK-B885
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 16, 2022 | K213984 | Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) | DQA | Substantially Equivalent | Shenzhen Zhengkang Technology Co., Ltd. | accessdata.fda.gov |
| March 12, 2021 | K203707 | Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 | FLL | Substantially Equivalent | Shenzhen Zhengkang Technology Co., Ltd. | accessdata.fda.gov |
| February 21, 2020 | K191894 | Upper Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Zhengkang Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Oximeter
Updated December 16, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.