FDA 510(k) Application Details - K232688

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

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510(K) Number K232688
Device Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant NeuroQore, Inc.
479 Jessie Street
San Francisco, CA 94103 US
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Contact Mehran Talebinejad
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Regulation Number 882.5805

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Classification Product Code OBP
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Date Received 09/01/2023
Decision Date 12/29/2023
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

FDA Source Information for K232688


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