QVT — Monitor For Opioid Induced Impairment Of Oxygenation Class II

FDA Device Classification

Classification Details

Product Code
QVT
Device Class
Class II
Regulation Number
868.2250
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN200011masimo corporationMasimo SafetyNetMarch 31, 2023