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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K172700
Device Name OEC One
Applicant
GE HUALUN MEDICAL SYSTEMS CO., LTD.
No1 YongChang North Road
Beijing Economic Technological Development Zone
Beijing,  CN 100176
Applicant Contact Lifeng Wang
Correspondent
GE HUALUN MEDICAL SYSTEMS CO., LTD.
No 1 Yong Chang North Road
Beijing Economic Technological Development Zone
Beijing,  CN 100176
Correspondent Contact Lifeng Wang
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received09/07/2017
Decision Date 11/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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