Anesthesiology
Masimo SafetyNet
Masimo Corporation
FDA-cleared AI medical device
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
FDA Submission Metadata
- Submission number
- DEN200011
- Decision date
- March 2023
- FDA panel
- Anesthesiology
- Product code
- QVT
- Clinical task (npj)
- triage
- Data modality (npj)
- Signals
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.