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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 K150975
Device Name Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors
Applicant
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
Hewlett-Packard Str. 2
Boeblingen, Baden Wuerttemberg,  DE 71034
Applicant Contact Michael Asmalsky
Correspondent
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
Hewlett-Packard Str. 2
Boeblingen, Baden Wuerttemberg,  DE 71034
Correspondent Contact Michael Asmalsky
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQA   DSB  
Date Received04/13/2015
Decision Date 06/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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