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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K253654
Device Name IntelliVue Measurement Rack 6000 (867317)
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 Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
BZC   BZQ   CBQ   CBR   CBS  
CCK   CCL   DQA   DSF   DSJ   DSK  
FLL   GWQ   GWS   KOI   MUD   NHO  
NHP   NHQ  
Date Received11/20/2025
Decision Date 03/30/2026
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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