K214072 is an FDA 510(k) clearance for the Masimo O3 Regional Oximeter System, 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 6, 2022, 130 days after receiving the submission on December 27, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K214072 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 27, 2021 |
| Decision Date | May 06, 2022 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MUD — Oximeter, Tissue Saturation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2700 |