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FDA 510(k) Application Details - K163502
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K163502
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
Biobot Surgical Pte Ltd
79, Ayer Rajah Crescent, #04-05/06
Singapore 139955 SG
Other 510(k) Applications for this Company
Contact
Lai Chee LIEW
Other 510(k) Applications for this Contact
Regulation Number
892.1570
More FDA Info for this Regulation Number
Classification Product Code
ITX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/14/2016
Decision Date
05/16/2017
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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