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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name detector and alarm, arrhythmia
510(k) Number K113125
Device Name INTELLIVUE MX40 PATIENT MONITOR
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Applicant Contact THERESA POOLE
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Correspondent Contact THERESA POOLE
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Codes
DQA   DRG   DRW   DSA   MHX  
MLD   MSX  
Date Received10/24/2011
Decision Date 11/17/2011
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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