510(k) K010942 ยท OWB Interventional Fluoroscopic X-Ray System
U04
| Applicant | Siemens Medical Solutions USA, Inc., Iselin NJ, US |
| Decision | Substantially Equivalent, Apr 12, 2001 |
| Received | Mar 29, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010942
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2012 | Siemens Medical Solutions USA, Inc Siemens Uroskop Access.
Fluoroscopic, image intensified x-ray system Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.