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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, network and communication, physiological monitors
510(k) Number K143057
Device Name M3290B Philips IntelliVue Information Center iX
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN ROAD
ANDOVER,  MA  01810
Applicant Contact Theresa Poole
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact Theresa Poole
Regulation Number870.2300
Classification Product Code
MSX  
Date Received10/24/2014
Decision Date 12/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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