FDA 510(k) Application Details - DEN240062

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240062
Device Name	Minder System
Applicant	Epi-Minder PTY LTD 384-388 Albert St Melbourne 3002 AU Other 510(k) Applications for this Company
Contact	Tracy Cameron Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2024
Decision Date	04/17/2025
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review