FDA 510(k) Application Details - K220946

Device Classification Name	More FDA Info for this Device
510(K) Number	K220946
Device Name	SURGIVISIO Device
Applicant	Ecential Robotics Zone Mayencin II, Parc Equation - BΓtiment 1, 2 avenue de Vignate Gieres 38610 FR Other 510(k) Applications for this Company
Contact	Mathilde Saulpic Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2022
Decision Date	04/15/2022
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