FDA Product Code QVT: Monitor For Opioid Induced Impairment Of Oxygenation
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
Leading manufacturers include Masimo Corporation.
1
Total
0
Cleared
1136d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Monitor For Opioid Induced Impairment Of Oxygenation Devices (Product Code QVT)
1 devices
About Product Code QVT - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QVT since 2023, with 0 receiving FDA clearance (average review time: 1136 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QVT devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →