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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K153654
Device Name Sentry WEB SmartInterp
Applicant
CareFusion Germany 234 GmbH
Leibnizstrasse 7
Hoechberg,  DE 97204
Applicant Contact Elmar Niedermeyer
Correspondent
CareFusion Germany 234 GmbH
Leibnizstrasse 7
Hoechberg,  DE 97204
Correspondent Contact Elmar Niedermeyer
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
BZC  
Date Received12/21/2015
Decision Date 09/16/2016
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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