510(k) K080813 ยท DXO Transducer, Pressure, Catheter Tip
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
| Applicant | Radi Medical Systems AB, Uppsala, SE |
| Decision | Substantially Equivalent, Jul 1, 2008 |
| Received | Mar 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080813
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.