510(k) K161019 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Uroview FD
| Applicant | Pausch Medical GmbH, Erlangen, DE |
| Decision | Substantially Equivalent, Aug 17, 2016 |
| Received | Apr 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161019
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2017 | Hans Pausch Rontgengeratebau Gmbh Pausch Uroview FD fluoroscopic X-ray system
UDI number (01)04260491620040
Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). Th Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.