510(k) K233200 ยท OWB Interventional Fluoroscopic X-Ray System
XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
| Applicant | GEMSS HEALTHCARE CO., LTD., Paju-Si, KR |
| Decision | Substantially Equivalent, Nov 16, 2023 |
| Received | Sep 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233200
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.