510(k) K230800 ยท KPR System, X-Ray, Stationary
XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
| Applicant | GEMSS HEALTHCARE CO., LTD., Paju-Si, KR |
| Decision | Substantially Equivalent, Nov 2, 2023 |
| Received | Mar 23, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230800
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.