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FDA 510(k) Application Details - K011397
Device Classification Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
More FDA Info for this Device
510(K) Number
K011397
Device Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant
PERSYST DEVELOPMENT CORP.
316 SKYLINE DR.
PRESCOTT, AZ 86303 US
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Contact
SCOTT B WILSON
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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
05/07/2001
Decision Date
08/03/2001
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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