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FDA 510(k) Application Details - K171184
Device Classification Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
More FDA Info for this Device
510(K) Number
K171184
Device Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant
Persyst Development Corporation
420 Stevens Avenue
Suite 210
Solana Beach, CA 92075 US
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Contact
Dari Darabbeigi
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OMB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/24/2017
Decision Date
09/21/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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