K162675 is an FDA 510(k) clearance for the Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on December 28, 2016, 93 days after receiving the submission on September 26, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K162675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2016 |
| Decision Date | December 28, 2016 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |