510(k) K111344 ยท OWB Interventional Fluoroscopic X-Ray System
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
| Applicant | Infimed, Inc., Liverpool NY, US |
| Decision | Substantially Equivalent, Jun 10, 2011 |
| Received | May 12, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111344
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.