1 device · 1 company · 2023
Product code QVT: Monitor For Opioid Induced Impairment Of Oxygenation
1 device under product code QVT, 2023, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Monitor For Opioid Induced Impairment Of Oxygenation. 21 CFR 868.2250, Class II. 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 MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Masimo SafetyNetDEN200011 · De Novo | Masimo Corporation | Anesthesiology | database entry |
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