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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 St. 2
Boeblingen,  DE 71034
Applicant Contact Michael Asmalsky
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard St. 2
Boeblingen,  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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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