510(k) K192453 ยท KPR System, X-Ray, Stationary
DIAMOND-5A/6A/8A
| Applicant | DRGEM Corporation, Gwangmyeong-Si, KR |
| Decision | Substantially Equivalent, Oct 1, 2019 |
| Received | Sep 9, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192453
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.