Data / Medical devices / China / Mianyang Meike Electronic Equipment Co.,ltd.
Mianyang Meike Electronic Equipment Co.,ltd.: FDA-registered device maker in Mianyang Sichuan, China, 3 510(k) clearances
Mianyang Meike Electronic Equipment Co.,ltd. is registered with the FDA (registration 3008595936) in Mianyang Sichuan, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 9, 2021. 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
- 3008595936
- Address
- No.63, Yinping Road, Longmen Town, Fucheng District, Mianyang Sichuan, China, 621000
- Owner or operator
- Mianyang Meike Electronic Equipment Co., Ltd. (10044130)
- Roles
- Manufacturer
- First device listed
- May 2, 2013
- Registered through
- 2026
- Brand names listed
- PBSV4.1 Palm Bladder Scanner, Palm Bladder Scanner, Palm Bladder Scanner - PBSV5.1, Vioscan
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 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 |
|---|---|---|---|---|---|---|
| June 9, 2021 | K210591 | Palm Bladder Scanner - PBSV7.1 | IYO | Substantially Equivalent | Mianyang Meike Electronic Equipment Co., Ltd. | accessdata.fda.gov |
| June 5, 2019 | K191307 | Palm Bladder Scanner - PBSV5.1 | IYO | Substantially Equivalent | Mianyang Meike Electronic Equipment Co., Ltd. | accessdata.fda.gov |
| March 20, 2013 | K130229 | PALM BLADDER SCANNER | IYO | Substantially Equivalent | Mianyang Meike Electronic Equipment Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated June 9, 2021. 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.