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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 K151063
Device Name Monitor B40
Applicant
GE MEDICAL SYSTEMS CHINA CO., LTD.
NO. 19 CHANGJIANG ROAD, NATIONAL HI-TECH DEV. ZONE
WUXI,  CN 214028
Applicant Contact Sun YanLi
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 WEST TOWER AVENUE
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 Received04/20/2015
Decision Date 12/15/2015
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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