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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,  GM 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 (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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