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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
Applicant
PHILIPS MEDICAL SYSTEMS
HEWLETT PACKARD STR. 2
BOBLINGEN,  DE D71034
Applicant Contact HERBERT VAN DYK
Correspondent
PHILIPS MEDICAL SYSTEMS
HEWLETT PACKARD STR. 2
BOBLINGEN,  DE D71034
Correspondent Contact HERBERT VAN DYK
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/24/2003
Decision Date 12/11/2003
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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