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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 K152258
Device Name T3 Software
Applicant
Etiometry, Inc.
119 Braintree St. Suite 210
Boston,  MA  02134
Applicant Contact DIMITAR BARONOV
Correspondent
Quintiles
5846 Cobblestone Lane
Waunakee,  WI  53597
Correspondent Contact RICHARD E. GALGON
Regulation Number870.2300
Classification Product Code
PLB  
Subsequent Product Code
MWI  
Date Received08/11/2015
Decision Date 03/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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