FDA 510(k) Application Details - K251210

Device Classification Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder

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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
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Contact Don Vaughn
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Regulation Number 882.5805

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Classification Product Code OBP
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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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