510(k) K100403 ยท DQA Oximeter
MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 23, 2010 |
| Received | Feb 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2011 | Masimo Corporation Masimo Hemoglobin
Pronto-7 with Rainbow 40 Technology for
easy-to-use spot-check testing of hemoglobin (SpHb),
SpO2, pulse rate, and perfusion index
Pronto-7 rainbow 4D Reusable Sensors are an accesso Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.