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FDA 510(k) Application Details - K161109
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K161109
Device Name
System, Image Processing, Radiological
Applicant
BIOBOT SURGICAL PTE LTD
2 WOODLANDS SPECTRUM 1,
#03-10, WOODLANDS SECTOR 1
Singapore 738068 SG
Other 510(k) Applications for this Company
Contact
Lai Chee LIEW
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/20/2016
Decision Date
10/06/2016
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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