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FDA 510(k) Application Details - K160131
Device Classification Name
More FDA Info for this Device
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 100176 CN
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Contact
LIFENG WANG
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Regulation Number
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Classification Product Code
OXO
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More FDA Info for this Product Code
Date Received
01/20/2016
Decision Date
06/21/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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