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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 K250453
Device Name IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
Applicant
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE 71034
Applicant Contact Monica Da Silva
Correspondent
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE 71034
Correspondent Contact Monica Da Silva
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   CCK   DPS   DQA   DRT  
DSF   DSJ   DSK   DXN   FLL   MLD  
MSX  
Date Received02/18/2025
Decision Date 09/02/2025
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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