510(k) K100102 ยท OWB Interventional Fluoroscopic X-Ray System
CS-SERIES-FP
| Applicant | Omega Medical Imaging, Inc., Sanford FL, US |
| Decision | Substantially Equivalent, Aug 31, 2010 |
| Received | Jan 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100102
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.