DeviceClearance

Product code QVT— Anesthesiology

Masimo SafetyNet

Classification name
Monitor For Opioid Induced Impairment Of Oxygenation
Device class
Class 2
Regulation
21 CFR 868.2250
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code QVT under 21 CFR 868.2250, via openFDA

Market context for product code QVT

FDA has cleared 1 device under product code QVT, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QVT

Recent clearances under product code QVT

Data sourced from openFDA. This site is unofficial and independent of the FDA.