510(k) K192364 ยท KPR System, X-Ray, Stationary
GXR-Series Diagnostic X-Ray System
| Applicant | DRGEM Corporation, Gwangmyeong-Si, KR |
| Decision | Substantially Equivalent, Sep 26, 2019 |
| Received | Aug 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192364
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.