FDA 510(k) Application Details - DEN230051

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230051
Device Name	Myocene
Applicant	Myocene Quai Banning 6 LiΦge 4000 BE Other 510(k) Applications for this Company
Contact	Jean-Yves Mignolet Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SDX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2023
Decision Date	01/17/2025
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review