510(k) K152813 ยท KPR System, X-Ray, Stationary
FS-500DDR Medical Radiographic X-Ray System
| Applicant | Orich Medical Equipment (Tianjin) Co., Ltd., Tianjin Economic Technological Developme, CN |
| Decision | Substantially Equivalent, Dec 2, 2016 |
| Received | Sep 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152813
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.