510(k) K200976 ยท IZL System, X-Ray, Mobile
SR-8230, SR-8230S Portable X-ray Unit
| Applicant | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), Shantou, CN |
| Decision | Substantially Equivalent, Jun 10, 2020 |
| Received | Apr 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200976
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.