FDA Product Code QXY: Oscillometric-based, Over-the-counter, Atrial Fibrillation Notification Feature
An Oscillometric-based, Over-the-counter, Atrial Fibrillation Notification Feature Is A Software Algorithm For Analysis Of Signals From An Oscillometric, Non-invasive Blood Pressure Measurement System To Screen For Possible Atrial Fibrillation In The Device User.
Leading manufacturers include Omron Healthcare, Inc..
1
Total
0
Cleared
330d
Avg days
2024
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Oscillometric-based, Over-the-counter, Atrial Fibrillation Notification Feature Devices (Product Code QXY)
1 devices
About Product Code QXY - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QXY since 2024, with 0 receiving FDA clearance (average review time: 330 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.