Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

QMW · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1420

Classification

FDA Product Code: QMW
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.1420
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A coronary artery disease risk indicator using acoustic heart signals is a device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk of presence of coronary artery disease, as an aid in cardiac analysis and diagnosis.

Market data

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

Source

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