FDA 510(k) Application Details - K182768

Device Classification Name	More FDA Info for this Device
510(K) Number	K182768
Device Name	TMS-Cobot TS MV
Applicant	Axilum Robotics 8 rue Schertz Strasbourg 67100 FR Other 510(k) Applications for this Company
Contact	Romuald Ginhoux Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2018
Decision Date	02/17/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review