FDA 510(k) Application Details - K232077

Device Classification Name	More FDA Info for this Device
510(K) Number	K232077
Device Name	Atalante X
Applicant	Wandercraft SAS 88 rue de Rivoli Paris 75004 FR Other 510(k) Applications for this Company
Contact	Matthieu Masselin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2023
Decision Date	12/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review