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 IDDEN190047
Device Name:CADScor System
ClassificationCoronary Artery Disease Risk Indicator From Acoustic Heart Signals
Applicant Acarix A/S ryvangs Alle 81 Hellerup,  DK 2900
ContactMette Munch
Product CodeQMW  
CFR Regulation Number870.1420 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice 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 BoardCardiovascular
Classification AdvisoryCardiovascular
Date Received2019-11-04
Decision Date2020-11-24
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
05700002223050 DEN190047 000
05700002223012 DEN190047 000

© 2021
This site is not affiliated with or endorsed by the FDA.