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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(without arrhythmia detection or alarms)
510(k) Number K041942
Device Name M2376A DEVICELINK SYSTEM
Original Applicant
PHILLIPS MEDICAL SYSTEMS
hewlett packard str. 2
boblingen,  DE d71034
Original Contact herbert van dyk
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/19/2004
Decision Date 07/23/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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