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FDA 510(k) Application Details - K133793
Device Classification Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
More FDA Info for this Device
510(K) Number
K133793
Device Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant
PERSYST DEVELOPMENT CORPORATION
12625 HIGH BLUFF DRIVE, SUITE 213
SAN DIEGO, CA 92130 US
Other 510(k) Applications for this Company
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
12/13/2013
Decision Date
05/19/2014
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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