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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name coronary artery disease risk indicator from acoustic heart signals
De Novo Number DEN190047
Device Name CADScor System
Requester
acarix a/s
ryvangs alle 81
hellerup,  DK 2900
Contact mette munch
Regulation Number870.1420
Classification Product Code
QMW  
Date Received11/04/2019
Decision Date 11/24/2020
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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