510(k) K100849 ยท IZI System, X-Ray, Angiographic
SYNC-RX SYSTEM, MODEL AS00010
| Applicant | Sync-Rx, Ltd., Lakewood CO, US |
| Decision | Substantially Equivalent, May 21, 2010 |
| Received | Mar 26, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100849
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.