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FDA 510(k) Application Details - K173460
Device Classification Name
Electroencephalograph
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
882.1400
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Classification Product Code
GWQ
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More FDA Info for this Product Code
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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