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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 K131032
Device Name PHILIPS SURESIGNS CENTRAL
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD
ANDOVER,  MA  01810
Applicant Contact MARY KRUITWAGEN
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD
ANDOVER,  MA  01810
Correspondent Contact MARY KRUITWAGEN
Regulation Number870.1025
Classification Product Code
MHX  
Date Received04/12/2013
Decision Date 08/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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