510(k) K093066 ยท OWB Interventional Fluoroscopic X-Ray System
I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
| Applicant | Infimed, Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Mar 16, 2010 |
| Received | Sep 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093066
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.