FDA 510(k) Application Details - DEN240014

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240014
Device Name	ARC-EX System
Applicant	Onward Medical Inc. 50 Milk Street Boston, MA 02109 US Other 510(k) Applications for this Company
Contact	Nathalie Gilat Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SDO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2024
Decision Date	12/19/2024
Decision	DENG -
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review