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

QXY · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1135

Classification

FDA Product Code: QXY
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.1135
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown