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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K122095
Device Name ICP TRIAGEMANAGER
Original Applicant
Emergo Europe Consulting BV
prinsessegracht 20
den haag,  NL 2514
Original Contact rachida ziani
Regulation Number870.2910
Classification Product Code
DRG  
Date Received07/12/2012
Decision Date 07/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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