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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 K113657
Models MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700, MX800, X2,MP2, MP5,MP5T, MP5SC, MP20, MP30
Device Name INTELLIVUE PATIENT MONITOR
Original Applicant
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
hewlett-packard-str. 2
boblingen,  GM d-71034
Original Contact manfred stever
Regulation Number870.1025
Classification Product Code
MHX  
Date Received12/12/2011
Decision Date 03/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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