QMW · Class II · 21 CFR 870.1420

FDA Product Code QMW: Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

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.

1
Total
0
Cleared
386d
Avg days
2020
Since

FDA 510(k) Cleared Coronary Artery Disease Risk Indicator From Acoustic Heart Signals Devices (Product Code QMW)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code QMW - Regulatory Context