510(k) K905458 ยท DQE Catheter, Oximeter, Fiber-Optic
SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER
| Applicant | Baxter Healthcare Corp, Irvine CA, US |
| Decision | Substantially Equivalent, Feb 7, 1991 |
| Received | Dec 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905458
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.