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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 K021912
Device Name M2376 DEVICELINK SYSTEM
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact DENISE HADLEY
Correspondent
PHILIPS MEDICAL SYSTEMS, INC.
3000 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact DENISE HADLEY
Regulation Number870.2300
Classification Product Code
MWI  
Date Received06/11/2002
Decision Date 06/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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