FDA 510(k) Application Details - K233621

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

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510(K) Number K233621
Device Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant Neuronetics
3222 Phoenixville Pike
Malvern, PA 19355 US
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Contact Amanda Pentecost
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Regulation Number 882.5805

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Classification Product Code OBP
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Date Received 11/13/2023
Decision Date 12/13/2023
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 K233621


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