510(k) K140041 ยท OWB Interventional Fluoroscopic X-Ray System
ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
| Applicant | Genoray Co., Ltd., Tustin CA, US |
| Decision | Substantially Equivalent, Nov 28, 2014 |
| Received | Jan 8, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140041
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.