FDA 510(k) Application Details - K231675

Device Classification Name	Generator, Lesion, Radiofrequency   More FDA Info for this Device
510(K) Number	K231675
Device Name	Generator, Lesion, Radiofrequency
Applicant	NeuroOne Medical Technologies Corp. 7599 Anagram Drive Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	Debra Kridner Other 510(k) Applications for this Contact
Regulation Number	882.4400   More FDA Info for this Regulation Number
Classification Product Code	GXD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2023
Decision Date	12/06/2023
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