FDA 510(k) Application Details - DEN230003

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230003
Device Name	Viz HCM
Applicant	Viz.ai, Inc. 201 Mission St., 12th Floor San Francisco, CA 94105 US Other 510(k) Applications for this Company
Contact	Gregory Ramina Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2023
Decision Date	08/03/2023
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