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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 K142732
Device Name T3 Software
Applicant
Etiometry, Inc.
119 Braintree St.
Boston,  MA  02134
Applicant Contact Dimitar Baronov
Correspondent
Quintiles Consulting
18 Bridie Lane
Norfolk,  MA  02056
Correspondent Contact Pamela J. Weagraff
Regulation Number870.2300
Classification Product Code
MWI  
Date Received09/23/2014
Decision Date 03/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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