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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K163065
Device Name T3 Software
Applicant
ETIOMETRY, INC.
119 BRAINTREE STREET
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
MWI  
Subsequent Product Code
PLB  
Date Received11/02/2016
Decision Date 05/26/2017
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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