The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo O3 Regional Oximeter System.
| Device ID | K162603 |
| 510k Number | K162603 |
| Device Name: | Masimo O3 Regional Oximeter System |
| Classification | Oximeter, Tissue Saturation |
| Applicant | MASIMO CORPORATION 52 DISCOVERY Irvine, CA 92618 |
| Contact | Marguerite Thomlinson |
| Correspondent | Marguerite Thomlinson MASIMO CORPORATION 52 DISCOVERY Irvine, CA 92618 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-19 |
| Decision Date | 2017-05-26 |
| Summary: | summary |