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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 K102562
Device Name INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800
Applicant
Philips Medizin Systeme Boblingen GmbH
Hewlett Packard St. 2
Boblingen,  DE D71034
Applicant Contact ANDREAS SUCHI
Correspondent
Philips Medizin Systeme Boblingen GmbH
Hewlett Packard St. 2
Boblingen,  DE D71034
Correspondent Contact ANDREAS SUCHI
Regulation Number870.1025
Classification Product Code
MHX  
Date Received09/07/2010
Decision Date 10/21/2010
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
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