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..
List of Oscillometric-based, Over-the-counter, Atrial Fibrillation Notification Feature devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Oscillometric-based, Over-the-counter, Atrial Fibrillation Notification Feature devices (product code QXY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →