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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K160131
Device Name OEC Elite MiniView
Applicant
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
NO.1 YONGCHANG NORTH ROAD, BEIJING ECON.&TECH.DEV.ZONE
BEIJING,  CN 100176
Applicant Contact LIFENG WANG
Correspondent
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
NO.1 YONGCHANG NORTH ROAD, BEIJING ECON.&TECH.DEV.ZONE
BEIJING,  CN 100176
Correspondent Contact LIFENG WANG
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received01/20/2016
Decision Date 06/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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