QVTClass II
Monitor For Opioid Induced Impairment Of Oxygenation
21 CFR 868.2250 / Anesthesiology
QVT is the FDA product code for Monitor For Opioid Induced Impairment Of Oxygenation, a class II device type, regulated under 21 CFR 868.2250. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QVT
- Device name
- Monitor For Opioid Induced Impairment Of Oxygenation
- FDA 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
- Regulation
- 21 CFR 868.2250
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QVT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 1 |
Applicants with the most clearances
Product code QVT| Applicant | Clearances |
|---|---|
| Masimo Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QVT.
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