FDA 510(k) Application Details - K220813

Device Classification Name	More FDA Info for this Device
510(K) Number	K220813
Device Name	ART-PLAN
Applicant	TheraPanacea PΘpiniΦre Cochin Paris SantΘ, 29 rue du Faubourg Saint-Jacques Paris 75014 FR Other 510(k) Applications for this Company
Contact	Edwin Lindsay Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2022
Decision Date	06/17/2022
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