FDA 510(k) Application Details - K173460

Device Classification Name Electroencephalograph

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510(K) Number K173460
Device Name Electroencephalograph
Applicant MemoryMD Inc.
205 East 42nd St 14th FL
New York, NY 10017 US
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Contact Abdus-Salaam Muwwakkil
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 11/07/2017
Decision Date 02/16/2018
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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