510(k) K211780 ยท OWB Interventional Fluoroscopic X-Ray System
ZEN-2090 Turbo
| Applicant | Genoray Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Mar 9, 2022 |
| Received | Jun 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211780
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.