510(k) K921309 ยท BTY Calculator, Predicted Values, Pulmonary Function
MODEL 508 PATIENT MONITOR
| Applicant | Criticare Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Dec 17, 1993 |
| Received | Mar 10, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921309
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.