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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(With Arrhythmia Detection Or Alarms)
510(k) Number K102495
Device Name M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMEN RD.
ANDOVER,  MA  01810 -1099
Applicant Contact THERESA POOLE
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMEN RD.
ANDOVER,  MA  01810 -1099
Correspondent Contact THERESA POOLE
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DSH   DSI   MLD   MSX  
Date Received08/31/2010
Decision Date 09/30/2010
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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