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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 K033680
Device Name M2376A PHILIPS DEVICE LINK SYSTEM
Original Applicant
PHILIPS MEDICAL SYSTEMS
hewlett packard str. 2
boblingen,  GM d71034
Original Contact herbert van dyk
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/24/2003
Decision Date 12/11/2003
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
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