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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 K133576
Device Name MONITOR B40
Applicant
GE MEDICAL SYSTEMS CHINA CO., LTD.
8200 WEST TOWER AVE
MILWAUKEE,  WI  53223
Applicant Contact ROBERT CASARSA
Correspondent
GE MEDICAL SYSTEMS CHINA CO., LTD.
8200 WEST TOWER AVE
MILWAUKEE,  WI  53223
Correspondent Contact ROBERT CASARSA
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   CBQ   CBR   CBS   CCK  
CCL   DQA   DRT   DSB   DSK   DXN  
FLL   GWQ   NHO   NHP   NHQ  
Date Received11/20/2013
Decision Date 02/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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