FDA 510(k) Application Details - K171051

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

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510(K) Number K171051
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 Tom Campbell
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Regulation Number 882.5805

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Classification Product Code OBP
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Date Received 04/10/2017
Decision Date 09/13/2017
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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