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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 K210906
Device Name IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Strasse 2
Boeblingen,  DE 71034
Applicant Contact Monica da Silva
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Strasse 2
Boeblingen,  DE 71034
Correspondent Contact Monica da Silva
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZC   BZQ   CBQ   CBR   CBS  
CCK   CCL   DPS   DQA   DRT   DSF  
DSJ   DSK   DXN   FLL   GWQ   GWS  
KLK   KOI   LKD   MLD   MSX   NHO  
NHP   NHQ  
Date Received03/26/2021
Decision Date 10/07/2021
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
Recalls CDRH Recalls
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