510(k) K103425 ยท OWB Interventional Fluoroscopic X-Ray System
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
| Applicant | Genoray America, Inc., Orange CA, US |
| Decision | Substantially Equivalent, Mar 29, 2011 |
| Received | Nov 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103425
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.