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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 K041401
Device Name MODIFICATION TO M2376A DEVICELINK 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 Received05/26/2004
Decision Date 06/04/2004
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
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