510(k) K100739 ยท KRB Probe, Thermodilution
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 7, 2010 |
| Received | Mar 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100739
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.