FDA 510(k) Application Details - K183704

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K183704
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
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	870.2920   More FDA Info for this Regulation Number
Classification Product Code	DXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2018
Decision Date	02/16/2019
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	Y
Expedited Review