510(k) K091918 ยท OWB Interventional Fluoroscopic X-Ray System
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
| Applicant | Genoray Co., Ltd., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 7, 2009 |
| Received | Jun 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091918
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.