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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(With Arrhythmia Detection Or Alarms)
510(k) Number K131829
Device Name INTELLIVUE PATIENT MONITOR
Applicant
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Hewlett-Packard St. 2
Boeblingen, Baden-Wuerttemberg,  DE D 71034
Applicant Contact HERBERT VAN DYK
Correspondent
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Hewlett-Packard St. 2
Boeblingen, Baden-Wuerttemberg,  DE D 71034
Correspondent Contact HERBERT VAN DYK
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZC   BZQ   CBR   CBS   CCK  
CCL   DPS   DQA   DRG   DRJ   DRQ  
DRS   DRT   DRW   DSA   DSF   DSH  
DSI   DSJ   DSK   DSP   DXG   DXN  
FLL   GWR   GWS   KLK   KOI   KRB  
KRC   LKD   MLC   MLD   MSX   NHO  
NHP   NHQ  
Date Received06/20/2013
Decision Date 08/16/2013
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
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