510(k) K193626 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Masimo Rad-97 Pulse CO-Oximeter and Accessories
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 10, 2020 |
| Received | Dec 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193626
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.