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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 K251146
Device Name IntelliVue Patient monitors MX400, MX450, MX500, MX550
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Strasse 2
Böblingen,  DE 71034
Applicant Contact Vasiliki Begkou
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Strasse 2
Böblingen,  DE 71034
Correspondent Contact Vasiliki Begkou
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZC   BZQ   CBQ   CBR   CBS  
CCK   CCL   DPS   DQA   DQK   DRT  
DSF   DSJ   DSK   DXN   FLL   GWQ  
GWS   KLK   KOI   LKD   MLD   MSX  
NHO   NHP   NHQ  
Date Received04/14/2025
Decision Date 10/17/2025
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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