510(k) K201770 ยท DQA Oximeter
Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Sep 24, 2020 |
| Received | Jun 29, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201770
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2024 | Masimo Corporation Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, Open, Classified |
DQA | None listed |
| Apr 12, 2024 | Masimo Corporation Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, 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.