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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 K150310
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
BZC   BZQ   CBQ   CBR   CBS  
CCK   CCL   DPS   DQA   DRG   DRJ  
DRQ   DRS   DRT   DRW   DSA   DSF  
DSH   DSJ   DSK   DSP   DXG   DXN  
FLL   GWS   KLK   KOI   KRB   KRC  
LKD   MHX   MLC   MLD   MSX   NHO  
NHP   NHQ   ORT  
Date Received02/09/2015
Decision Date 05/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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