FDA 510(k) Application Details - K243460

Device Classification Name	Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder   More FDA Info for this Device
510(K) Number	K243460
Device Name	Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant	Brain Ultimate, Inc. 5910 Shiloh Road East Alpharetta, GA 30005 US Other 510(k) Applications for this Company
Contact	Frank Ge 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	11/08/2024
Decision Date	04/17/2025
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