Monitor For Opioid Induced Impairment Of Oxygenation
Medical specialty
Anesthesiology
Device class
2
Regulation number
868.2250
Review panel
AN
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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