510(k) K864613 ยท DQA Oximeter
502 OXYGEN SATURATION MONITOR
| Applicant | Criticare Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Mar 4, 1987 |
| Received | Nov 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864613
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.