FDA 510(k) Application Details - K212373

Device Classification Name	More FDA Info for this Device
510(K) Number	K212373
Device Name	Sim&Size
Applicant	Sim&Cure 95 rue Pierre Flourens BΓtiment H Montpellier 34090 FR Other 510(k) Applications for this Company
Contact	Caroline Oziel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2021
Decision Date	01/27/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review