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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 K181831
Device Name IntelliVue Multi-Measurement Module MMX
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
DRQ   DSI   DSJ   DSK   DXG  
DXN   MLD  
Date Received07/09/2018
Decision Date 11/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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