FDA 510(k) Application Details - K133408

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

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510(K) Number K133408
Device Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant NEURONETICS
3222 PHOENIXVILLE PIKE
MALVERN, PA 19355-1245 US
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Contact JUDY P WAYS, PH.D.
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Regulation Number 882.5805

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Classification Product Code OBP
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Date Received 11/06/2013
Decision Date 03/28/2014
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



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