510(k) K190497 ยท OWB Interventional Fluoroscopic X-Ray System
Ziehm 8000
| Applicant | Ziehm Imaging GmbH, Nuremberg, DE |
| Decision | Substantially Equivalent, Nov 20, 2019 |
| Received | Feb 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190497
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.