FDA 510(k) Application Details - K171124

Device Classification Name Electroencephalograph

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510(K) Number K171124
Device Name Electroencephalograph
Applicant Nihon Kohden Corporation
1-31-4 Nisahiochiai, Shinjuku-Ku
Tokyo 161-8560 JP
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Contact Tom Bento
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 04/17/2017
Decision Date 08/25/2017
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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