510(k) K070834 ยท OWB Interventional Fluoroscopic X-Ray System
CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
| Applicant | Omega Medical Imaging, Inc., Sanford FL, US |
| Decision | Substantially Equivalent, May 18, 2007 |
| Received | Mar 27, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070834
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.