510(k) K181943 ยท OWB Interventional Fluoroscopic X-Ray System
OSCAR (OSCAR Prime, OSCAR Classic)
| Applicant | Genoray Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Aug 17, 2018 |
| Received | Jul 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181943
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.