510(k) K053016 ยท DXO Transducer, Pressure, Catheter Tip
WIRELESS PHYSIOLOGIC MONITORING SYSTEM
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 30, 2005 |
| Received | Oct 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053016
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.