QXY

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 870.1135

Medical specialty

Cardiovascular

FDA 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.

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