Data / Medical devices / China / Shenzhen Sino-K Medical Technology Co., Ltd.
Shenzhen Sino-K Medical Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Shenzhen Sino-K Medical Technology Co., Ltd. is registered with the FDA (registration 3015616170) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 30, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015616170
- Address
- 4th Floor, Building 2, West Side of Xixiang Veterans Industry City, Gongle Community, Xixiang Street Baoan District, Shenzhen Guangdong, China, 518101
- Owner or operator
- Shenzhen SINO-K Medical Technology Co., Ltd. (10084033)
- Roles
- Manufacturer
- First device listed
- January 11, 2022
- Registered through
- 2026
- Brand names listed
- Disposable NIBP Cuff: SC0101, SC0102, SC0103, SC0104, SC0105, SC0106, SC0107, SC0108, SC0109, SC0110, SC0111, SC0112, Disposable SpO2 Sensor (model: SP1119, SP1119A), Disposable SpO2 Sensor (model: SP1319, SP1319A, SP1219, SP1219A, SP1019, SP1019A, SP1002, SP1003, SP1015A), Disposable Temperature Probe (model: ST5105A, ST6105A), ECG/EKG cable and lead-wires (model: SG31XXS, SG31XXP, SG51XXS, SG51XXP), ECG/EKG cable and lead-wires (model: SG32XXS, SG32XXP, SG52XXS, SG52XXP), ECG/EKG cable and lead-wires (model: SK11XXB, SK12XXB, SK11XXN, SK12XXN), Reusable NIBP Cuff: SC1311, SC1511, SC1611, SC1711, SC1811 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Manufacturer | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 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 |
|---|---|---|---|---|---|---|
| August 30, 2023 | K231961 | NIBPCuff | DXQ | Substantially Equivalent | Shenzhen Sino-K Medical Technology Co.,Ltd | accessdata.fda.gov |
| August 25, 2023 | K223807 | Reusable Temperature Probe, Disposable Temperature Probe | FLL | Substantially Equivalent | Shenzhen Sino-K Medical Technology Co.,Ltd | accessdata.fda.gov |
| January 24, 2020 | K192608 | Disposable SpO2 Sensor | DQA | Substantially Equivalent | Shenzhen Sino-K Medical Technology Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Blood Pressure Cuff
- All makers of Continuous Measurement Thermometer
- All makers of Cable, Electrode
Updated August 30, 2023. 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.