FDA 510(k) Application Details - K213479

Device Classification Name	More FDA Info for this Device
510(K) Number	K213479
Device Name	D▓RS and D▓RS 9090
Applicant	Stephanix 10, rue Jean Moulin Z.I du Bayon La Ricamarie 42150 FR Other 510(k) Applications for this Company
Contact	Sandie Perret 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	10/29/2021
Decision Date	12/23/2021
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