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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 K060541
Device Name THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS
Applicant
PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH
HEWLETT PACKARD STR. 2
BOBLINGEN,  DE D 71034
Applicant Contact HERBERT VAN DYK
Correspondent
PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH
HEWLETT PACKARD STR. 2
BOBLINGEN,  DE D 71034
Correspondent Contact HERBERT VAN DYK
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   CBQ   CBR   CBS   CCK  
CCL   NHO   NHP   NHQ  
Date Received03/01/2006
Decision Date 03/24/2006
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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