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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 K122439
Device Name INTELLIVUE PATIENT MONITOR
Applicant
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR. 2
BOEBLINGEN,  DE 71034
Applicant Contact HERBERT VAN DYK
Correspondent
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR. 2
BOEBLINGEN,  DE 71034
Correspondent Contact HERBERT VAN DYK
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZC   BZQ   CBQ   CBR   CBS  
CCK   CCL   DPS   DQA   DRG   DRJ  
DRQ   DRS   DRT   DRW   DSA   DSB  
DSF   DSH   DSI   DSJ   DSK   DXG  
DXN   FLL   GWR   GWS   KLK   KOI  
KRB   KRC   LKD   MLC   MLD   MSX  
NHO   NHP   NHQ  
Date Received08/10/2012
Decision Date 08/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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