510(k) K161976 ยท OWB Interventional Fluoroscopic X-Ray System
Ziehm Solo FD
| Applicant | Ziehm Imaging GmbH, Nuremberg, DE |
| Decision | Substantially Equivalent, Oct 6, 2016 |
| Received | Jul 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161976
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2017 | Ziehm Imaging Inc Ziehm Imaging solo FD Mobile Fluoroscopic C-arm Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.