Data / Medical devices / China / Xuzhou Kaixin Electronic Instrument Co., Ltd.
Xuzhou Kaixin Electronic Instrument Co., Ltd.: FDA-registered device maker in Xuzhou Jiangsu, China, 1 510(k) clearance
Xuzhou Kaixin Electronic Instrument Co., Ltd. is registered with the FDA (registration 3012387143) in Xuzhou Jiangsu, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 7, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012387143
- Address
- Kaixin Mansion, C-01, Economic Development Zone, Xuzhou, Jiangsu,China., Xuzhou Jiangsu, China, 221004
- Owner or operator
- Xuzhou Kaixin Electronic Instrument Co., Ltd. (10088872)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 18, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| July 7, 2023 | K223448 | Bladder Scanner Model: BVT02 | IYO | Substantially Equivalent | Xuzhou Kaixin Electronic Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
Updated July 7, 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.