510(k) K083384 ยท DQO Catheter, Intravascular, Diagnostic
THERMODILUTION CATHETER
| Applicant | Biosensors Intl. Pte. , Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Jan 5, 2010 |
| Received | Nov 17, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083384
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.