FDA 510(k) Application Details - K203659

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K203659
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	Biobot Surgical Pte Ltd 2 Woodlands Spectrum l, #03-10 Woodlands Sector l Singapore 738068 SG Other 510(k) Applications for this Company
Contact	Lim Yan Shin Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2020
Decision Date	07/08/2021
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