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FDA 510(k) Application Details - K251210
Device Classification Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
More FDA Info for this Device
510(K) Number
K251210
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
04/18/2025
Decision Date
06/27/2025
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
FDA Source Information for K251210
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