DEN200076 is an FDA 510(k) submission for the ORi. This device is classified as a Hyperoxia Monitoring Device Adjunct To Pulse Oximetry (Class II - Special Controls, product code QWE).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Not Cleared (DENG) decision on October 12, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2720. A Hyperoxia Monitoring Device Adjunct To Pulse Oximetry Is A Device That Monitors Elevated Hemoglobin Oxygen Saturation Levels As An Adjunct To Arterial Oxygen Saturation Monitoring..
| 510(k) Number | DEN200076 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 21, 2020 |
| Decision Date | October 12, 2023 |
| Days to Decision | 1025 days |
| Submission Type | Direct |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | QWE — Hyperoxia Monitoring Device Adjunct To Pulse Oximetry |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2720 |
| Definition | A Hyperoxia Monitoring Device Adjunct To Pulse Oximetry Is A Device That Monitors Elevated Hemoglobin Oxygen Saturation Levels As An Adjunct To Arterial Oxygen Saturation Monitoring. |