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FDA 510(k) Application Details - K182181
Device Classification Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
More FDA Info for this Device
510(K) Number
K182181
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
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Classification Product Code
OMB
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More FDA Info for this Product Code
Date Received
08/13/2018
Decision Date
11/29/2018
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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