FDA 510(k) Application Details - K233742

Device Classification Name	More FDA Info for this Device
510(K) Number	K233742
Device Name	CloudTMS Edge for OCD
Applicant	TeleEMG, LLC 167 Poinsettia Pl Los Angeles, CA 90036 US Other 510(k) Applications for this Company
Contact	Joe Jabre 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	11/22/2023
Decision Date	12/22/2023
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