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FDA 510(k) Application Details - K171800
Device Classification Name
More FDA Info for this Device
510(K) Number
K171800
Device Name
OEC Elite MiniView
Applicant
GE Hualun Medical Systems Co.Ltd.
No1 YongChang North Road,
Beijing Economic Technological Development Zone
Beijing 100176 CN
Other 510(k) Applications for this Company
Contact
Lifeng Wang
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2017
Decision Date
07/12/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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