DeviceClearance

Product code QWE— Anesthesiology

ORi

Classification name
Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Device class
Class 2
Regulation
21 CFR 870.2720
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QWE under 21 CFR 870.2720, via openFDA

Market context for product code QWE

FDA has cleared 1 device under product code QWE, 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 QWE

Recent clearances under product code QWE

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