510(k) K042536 ยท DQA Oximeter
MASIMO SET RAD 57 PULSE CO-OXIMETER
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 19, 2005 |
| Received | Sep 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042536
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2006 | Masimo Corporation Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.