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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K151681
Device Name IntelliVue Patient Monitor
Applicant
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR. 2
BOEBLINGEN,  DE 71034
Applicant Contact JOHANNES SCHMID
Correspondent
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR. 2
BOEBLINGEN,  DE 71034
Correspondent Contact JOHANNES SCHMID
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Codes
DRQ   DSJ   DSK   DXG   DXN  
MHX   MLD  
Date Received06/22/2015
Decision Date 07/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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