510(k) K211140 ยท DQA Oximeter
Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O
| Applicant | Stryker Sustainability Solutions, Tempe AZ, US |
| Decision | Substantially Equivalent, Mar 8, 2022 |
| Received | Apr 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211140
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.