FDA 510(k) Application Details - K200833

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K200833
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	VivaQuant Inc. 4339 Nancy Place, Suite 100 St. Paul, MN 55126 US Other 510(k) Applications for this Company
Contact	Brian Brockway Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MLO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2020
Decision Date	09/02/2020
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