510(k) K212555 ยท DQA Oximeter
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
| Applicant | Covidien, LLC, Boulder CO, US |
| Decision | Substantially Equivalent, May 6, 2022 |
| Received | Aug 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212555
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.