510(k) K103416 ยท OWB Interventional Fluoroscopic X-Ray System
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
| Applicant | Infimed, Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Mar 17, 2011 |
| Received | Nov 22, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103416
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.