DEN200011 is an FDA 510(k) submission for the Masimo SafetyNet. This device is classified as a Monitor For Opioid Induced Impairment Of Oxygenation (Class II - Special Controls, product code QVT).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Not Cleared (DENG) decision on March 31, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2250. A Monitor For Opioid Induced Impairment Of Oxygenation Is A Device That Uses Sensor Hardware And Software Algorithms To Detect Desaturations Of Arterial Oxygen Saturation Resulting From Opioid Overdose.
| 510(k) Number | DEN200011 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 19, 2020 |
| Decision Date | March 31, 2023 |
| Days to Decision | 1136 days |
| Submission Type | Direct |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | QVT — Monitor For Opioid Induced Impairment Of Oxygenation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2250 |
| Definition | A Monitor For Opioid Induced Impairment Of Oxygenation Is A Device That Uses Sensor Hardware And Software Algorithms To Detect Desaturations Of Arterial Oxygen Saturation Resulting From Opioid Overdose |