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FDA 510(k) Application Details - K172869
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K172869
Device Name
System, X-Ray, Stationary
Applicant
GE Hualun Medical Systems Co.Ltd.
No.1 YongChang North Road,
Beijing Economic Technological Development Zone
Beijing 100176 CN
Other 510(k) Applications for this Company
Contact
Kenny Ma
Other 510(k) Applications for this Contact
Regulation Number
892.1680
More FDA Info for this Regulation Number
Classification Product Code
KPR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/20/2017
Decision Date
10/20/2017
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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