FDA 510(k) Application Details - K231350

Device Classification Name	More FDA Info for this Device
510(K) Number	K231350
Device Name	OCD MT Cap (85-00397-000)
Applicant	Neuronetics 3222 Phoenixville Pike Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Amanda Pentecost Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QCI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2023
Decision Date	06/08/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review