QMWClass II
Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
Cardiovascular · 21 CFR 870.1420
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.
MDR events0All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances1All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
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Most-reported manufacturers
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Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
1 clearances for this product code