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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 K123900
Device Name SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Applicant Contact MARY KRUITWAGEN
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Correspondent Contact MARY KRUITWAGEN
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CCK   DQA   DRT   DSA   DSJ  
DSK   DXN   FLL  
Date Received12/18/2012
Decision Date 04/18/2013
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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