Product code QWE

Device name
Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Medical specialty
Anesthesiology
Device class
2
Regulation number
870.2720
Review panel
AN
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset