FDA 510(k) Application Details - K222171

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

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510(K) Number K222171
Device Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant Magstim Company Ltd
Spring Gardens
Whitland SA340HR 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 07/21/2022
Decision Date 01/13/2023
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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