FDA 510(k) Application Details - K171902

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

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510(K) Number K171902
Device Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant Nexstim Plc
Elimaenkatu 9b
Helsinki 00510 FI
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Contact Rainer Harjunpaa
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Regulation Number 882.5805

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Classification Product Code OBP
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Date Received 06/26/2017
Decision Date 11/10/2017
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

FDA Source Information for K171902


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