510(k) K190560 ยท MUD Oximeter, Tissue Saturation
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
| Applicant | Nonin Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, May 2, 2019 |
| Received | Mar 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190560
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.