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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 K161531
Device Name IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800
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
DRT   DSI   DSJ   DSK   DXG  
DXN   MLD  
Date Received06/02/2016
Decision Date 07/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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