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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
Applicant
Phillips Medical Systems
Hewlett Packard St. 2
Boblingen,  DE D71034
Applicant Contact HERBERT VAN DYK
Correspondent
Phillips Medical Systems
Hewlett Packard St. 2
Boblingen,  DE D71034
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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