Data / Medical devices / China / Xinkang Medical Instrument Co. Ltd.
Xinkang Medical Instrument Co. Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Xinkang Medical Instrument Co. Ltd. is registered with the FDA (registration 3017953522) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 1, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017953522
- Address
- 808, Building 6, Hengda Fashion Valley Building (East District), Fulong Road, Shanghenglang Community Dalang Street, Longhua District, Shenzhen Guangdong, China, 518100
- Owner or operator
- Xinkang Medical Instrument Co. Ltd. (10078983)
- Roles
- Manufacturer
- First device listed
- November 12, 2020
- Registered through
- 2026
- Brand names listed
- ECG Cables and Leadwires, Model: G2202B10A, G2202C10A, G2202S10A, E2101C5A, E2101C3A, E2101S3A, E2101S5A, Xinakng, Nellcor 9pin Oximax Disposable Adult L type Non-woven Spo2 Sensor, model: XDBN, Xinakng, Nellcor 9pin Oximax Disposable Adult Non-woven Spo2 Sensor, model: XDAN, Xinakng, Nellcor 9pin Oximax Disposable Pediatric Non-woven Spo2 Sensor, model: XDPN, Xinkang, BCI 9Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSAF1, Xinkang, BCI 9Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAS1, Xinkang, BCI 9Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSPF1, Xinkang, BCI 9Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSPS1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 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 |
|---|---|---|---|---|---|---|
| October 1, 2020 | K201359 | ECG Cables and Leadwires | DSA | Substantially Equivalent | Xinkang Medical Instrument Co. , Ltd. | accessdata.fda.gov |
| August 19, 2020 | K201360 | Reusable and Disposable SpO2 Sensors | DQA | Substantially Equivalent | Xinkang Medical Instrument Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 1, 2020. 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.