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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
Device Name INTELLIVUE PATIENT MONITOR
Applicant
Philips Medizin Systeme Boblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE D-71034
Applicant Contact MANFRED STEVER
Correspondent
Philips Medizin Systeme Boblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE D-71034
Correspondent Contact MANFRED STEVER
Regulation Number870.1025
Classification Product Code
MHX  
Date Received12/12/2011
Decision Date 03/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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