510(k) DEN190047
DEN190047 is an FDA 510(k) premarket notification submitted by Acarix A/S for the device "CADScor System". The FDA issued a decision of De Novo Granted on November 24, 2020. The device falls under product code QMW (Coronary Artery Disease Risk Indicator From Acoustic Heart Signals), a Class II device regulated under 21 CFR 870.1420.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 24, 2020
- Date Received
- November 4, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
- Device Class
- Class II
- Regulation Number
- 870.1420
- Review Panel
- CV
- Submission Type
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.