FDA 510(k) Application Details - K162935

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

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510(K) Number K162935
Device Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant MAGSTIM COMPANY LTD.
SPRING GARDENS
Whitland SA34 0HR GB
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Contact Kevyn Beard
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Regulation Number 882.5805

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Classification Product Code OBP
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Date Received 10/20/2016
Decision Date 03/10/2017
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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