FDA 510(k) Application Details - K213543

Device Classification Name	Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder   More FDA Info for this Device
510(K) Number	K213543
Device Name	Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant	Neuronetics, Inc 3222 Phoenixville Pike Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	Fred Cowdery 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	11/08/2021
Decision Date	12/10/2021
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