Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

What Is It?

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.

How Is QMW Classified?

Coronary Artery Disease Risk Indicator From Acoustic Heart Signals is FDA product code QMW, Class 2, 21 CFR 870.1420.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.