510(k) K163140 ยท OWB Interventional Fluoroscopic X-Ray System
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
| Applicant | Gemss Medical Systems Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, May 26, 2017 |
| Received | Nov 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163140
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.