K162603 is an FDA 510(k) clearance for the Masimo O3 Regional Oximeter System. This device is classified as a Oximeter, Tissue Saturation (Class II - Special Controls, product code MUD).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on May 26, 2017, 249 days after receiving the submission on September 19, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K162603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2016 |
| Decision Date | May 26, 2017 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MUD — Oximeter, Tissue Saturation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |