510(k) K080238 ยท DQA Oximeter
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, May 12, 2008 |
| Received | Jan 31, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2015 | Masimo Corporation rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpC Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.