FDA 510(k) Application Details - K201060

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K201060
Device Name	Computer, Diagnostic, Programmable
Applicant	Cordiana Medical Informatics AG Platz 4 Root 6039 CH Other 510(k) Applications for this Company
Contact	Johan Sandberg Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2020
Decision Date	11/16/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review