510(k) K213676 ยท DQA Oximeter
Masimo Rad-G with Temperature
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 16, 2023 |
| Received | Nov 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213676
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2024 | Masimo Corporation Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, Open, Classified |
DQA | None listed |
| Apr 12, 2024 | Masimo Corporation Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, Open, Classified |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.