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

Device Identifier	submissionNumber	Supplement
05700002223050	DEN190047	000
05700002223012	DEN190047	000