Monitor For Opioid Induced Impairment Of Oxygenation
The Monitor for Opioid Induced Impairment of Oxygenation is a device that uses sensor hardware and software algorithms to detect arterial oxygen desaturation events resulting from opioid overdose, providing real-time monitoring to alert caregivers to hypoxic episodes in patients receiving opioid medications. Classified as FDA Class 2 under regulation 868.2250, it requires 510(k) clearance in the Anesthesiology specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QVT
- Device Class
- FDA class 2
- Regulation Number
- 868.2250
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200011 | Masimo SafetyNet | Mar 31, 2023 | Unknown | Masimo Corporation |