510(k) K180046 ยท DQA Oximeter
Masimo Rad-97 and Accessories
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 23, 2018 |
| Received | Jan 8, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180046
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2023 | Masimo Corporation Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 Open, Classified |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.