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FDA 510(k) Application Details - K192453
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K192453
Device Name
System, X-Ray, Stationary
Applicant
DRGEM Corporation
7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro
Gwangmyeong-si 14322 KR
Other 510(k) Applications for this Company
Contact
Ki-Nam Yang
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
09/09/2019
Decision Date
10/01/2019
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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