510(k) K160065 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
| Applicant | Gemss Medical Systems Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, May 20, 2016 |
| Received | Jan 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160065
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.