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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K032858
Device Name THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
Applicant
Philips Medizin Systeme Boblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE D 71034
Applicant Contact HAUKE SCHIK
Correspondent
Philips Medizin Systeme Boblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE D 71034
Correspondent Contact HAUKE SCHIK
Regulation Number870.1025
Classification Product Code
DSI  
Date Received09/12/2003
Decision Date 10/10/2003
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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