# Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
> **Product code: QWE** · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 870.2720
## Classification
- **FDA Product Code:** QWE
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.2720
- **Review panel:** AN
- **Medical specialty:** Anesthesiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A hyperoxia monitoring device adjunct to pulse oximetry is a device that monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QWE)
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