The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo O3 Regional Oximeter System.
| Device ID | K201432 |
| 510k Number | K201432 |
| Device Name: | Masimo O3 Regional Oximeter System |
| Classification | Oximeter, Tissue Saturation |
| Applicant | Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Contact | Sindura Penubarthi |
| Correspondent | Sindura Penubarthi 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 | 2020-06-01 |
| Decision Date | 2020-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997014557 | K201432 | 000 |
| 00843997013888 | K201432 | 000 |