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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 K083228
Device Name PHILIPS INTELLIVUE MP5 PATIENT MONITOR
Applicant
Philips Medizin Systeme Boblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE D-71034
Applicant Contact JENS-PETER SEHER
Correspondent
Philips Medizin Systeme Boblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE D-71034
Correspondent Contact JENS-PETER SEHER
Regulation Number870.1025
Classification Product Code
MHX  
Date Received11/03/2008
Decision Date 11/24/2008
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
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