QXY

Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature

Product code

QXY

Device name

Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature

Device class

Class 2

21 CFR

21 CFR 870.1135

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-10-08.