FDA 510(k) Application Details - DEN190047

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190047
Device Name	CADScor System
Applicant	Acarix A/S Ryvangs Alle 81 Hellerup 2900 DK Other 510(k) Applications for this Company
Contact	Mette Munch Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QMW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2019
Decision Date	11/24/2020
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review