CADScor System
Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
Acarix A/S
The following data is part of a De Novo classification by Acarix A/s with the FDA for Cadscor System.
Pre-market Notification Details
DeNovo ID | DEN190047 |
Device Name: | CADScor System |
Classification | Coronary Artery Disease Risk Indicator From Acoustic Heart Signals |
Applicant | Acarix A/S ryvangs Alle 81 Hellerup, DK 2900 |
Contact | Mette Munch |
Product Code | QMW |
CFR Regulation Number | 870.1420 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
Review Advisory Board | Cardiovascular |
Classification Advisory | Cardiovascular |
Type | Direct |
Date Received | 2019-11-04 |
Decision Date | 2020-11-24 |
Reclassification Order: | Reclassification Order |
NIH GUDID Devices
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.