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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multivariate vital signs index
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
Applicant Contact Gary Conkright
Correspondent
EXPERIEN GROUP, LLC
755 N MATHILDA AVENUE
Suite 100
SUNNYVALE,  CA  94085
Correspondent Contact Michael J Billig
Regulation Number870.2300
Classification Product Code
PLB  
Date Received09/08/2014
Decision Date 06/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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