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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 K153702
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 Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DSH   DSI   MLD   MSX   OUG  
Date Received12/23/2015
Decision Date 06/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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