510(k) K964821 ยท DQA Oximeter
COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67
| Applicant | Ventrex, Inc., Ventura CA, US |
| Decision | Substantially Equivalent, Jul 16, 1997 |
| Received | Dec 2, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964821
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.