Product code QXY

Device name

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

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.1135

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset