FDA Product Code QWE: Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
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.
Leading manufacturers include Masimo Corporation.
1
Total
0
Cleared
1025d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Hyperoxia Monitoring Device Adjunct To Pulse Oximetry Devices (Product Code QWE)
1 devices
About Product Code QWE - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QWE since 2023, with 0 receiving FDA clearance (average review time: 1025 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QWE devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →