FDA 510(k) Application Details - K243319

Device Classification Name	Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder   More FDA Info for this Device
510(K) Number	K243319
Device Name	Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant	Neuromodulatory Devices & Applications 501 W. Broadway Suite 1025 San Diego, CA 92101 US Other 510(k) Applications for this Company
Contact	Don Vaughn Other 510(k) Applications for this Contact
Regulation Number	882.5805   More FDA Info for this Regulation Number
Classification Product Code	OBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2024
Decision Date	02/13/2025
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