QVT — Monitor For Opioid Induced Impairment Of Oxygenation Class II
FDA product code QVT covers "Monitor For Opioid Induced Impairment Of Oxygenation", a Class II medical device regulated under 21 CFR 868.2250. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QVT
- Device Class
- Class II
- Regulation Number
- 868.2250
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200011 | masimo corporation | Masimo SafetyNet | March 31, 2023 |