QXYClass II
Oscillometric-based, Over-the-counter, Atrial Fibrillation Notification Feature
Cardiovascular · 21 CFR 870.1135
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.
MDR events0All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances1All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Product problems
Reported product problem codes, most common first
No data available.
No trend to chart.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
1 clearances for this product code