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FDA 510(k) Application Details - K170138
Device Classification Name
Electroencephalograph
More FDA Info for this Device
510(K) Number
K170138
Device Name
Electroencephalograph
Applicant
BIOSERENITY
47 boulevard de l'Hopital
Paris 75013 FR
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Contact
Quang TRAN
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
GWQ
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More FDA Info for this Product Code
Date Received
01/17/2017
Decision Date
12/26/2017
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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