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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 K041235
Device Name PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard St. 2
Boeblingen, Bw,  DE D-71034
Applicant Contact MARKUS STACHA
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard St. 2
Boeblingen, Bw,  DE D-71034
Correspondent Contact MARKUS STACHA
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Code
DQA  
Date Received05/11/2004
Decision Date 06/04/2004
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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