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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 K181314
Device Name IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Str. 2
Böblingen,  DE 71034
Applicant Contact Stefan Breuer
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Str. 2
Böblingen,  DE 71034
Correspondent Contact Stefan Breuer
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DSI   DSJ   DSK   DXG   DXN  
KRB   MLD  
Date Received05/17/2018
Decision Date 09/04/2018
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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