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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 K022920
Device Name M2376A DEVICELINK SYSTEM
Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd. ms 0490
andover,  MA  01810 1099
Contact barry wyshogrod
Regulation Number870.2300
Classification Product Code
MWI  
Date Received09/04/2002
Decision Date 09/17/2002
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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