510(k) K033296 ยท DQA Oximeter
MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
| Applicant | Masimo Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 19, 2004 |
| Received | Oct 14, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033296
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2023 | Masimo Corporation Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 Open, Classified |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.