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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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