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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 K252726
Device Name IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Strasse 2
Böblingen,  DE 71034
Applicant Contact Daniel Potocic
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Strasse 2
Böblingen,  DE 71034
Correspondent Contact Siegfried Breitling
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQA   DRT   DSI   DSJ   DXN  
FLL   MLD  
Date Received08/28/2025
Decision Date 02/06/2026
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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