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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 K160951
Device Name Philips Efficia CMS200 Central Monitoring System
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  
Date Received04/05/2016
Decision Date 05/05/2016
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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