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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 K052801
Device Name INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard St. 2
Boeblingen, Baden-Wuerttemberg,  DE D 71034
Applicant Contact HAUKE SCHIK
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard St. 2
Boeblingen, Baden-Wuerttemberg,  DE D 71034
Correspondent Contact HAUKE SCHIK
Regulation Number870.1025
Classification Product Code
MHX  
Date Received10/03/2005
Decision Date 11/02/2005
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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