FDA 510(k) Application Details - K202547

Device Classification Name	More FDA Info for this Device
510(K) Number	K202547
Device Name	Surgivisio system
Applicant	Surgivisio Zone Mayencin II, Parc Equation - BΓtiment 1, 2 avenue de Vignate GiΦres 38610 FR Other 510(k) Applications for this Company
Contact	Vincent Lere 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	09/02/2020
Decision Date	03/26/2021
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