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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 K171801
Device Name IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Str.-2
Boeblingen,  DE 71034
Applicant Contact Markus Stacha
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Str.-2
Boeblingen,  DE 71034
Correspondent Contact Markus Stacha
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQA   DRT   DSI   DSJ   DXN  
FLL   MLD  
Date Received06/16/2017
Decision Date 10/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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