510(k) K193242 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Feb 27, 2020 |
| Received | Nov 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193242
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.