FDA 510(k) Application Details - K142512

Device Classification Name	More FDA Info for this Device
510(K) Number	K142512
Device Name	Personalized Physiology Analytics Engine software
Applicant	VGBio, Inc (DBA PhysIQ) 1415 West Diehl Road, Suite 150 Naperville, IL 60563 US Other 510(k) Applications for this Company
Contact	Gary Conkright Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2014
Decision Date	06/11/2015
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