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510(k) K121119

BNA ANALYSIS SYSTEM by Eiminda , Ltd. — Product Code OLU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2014
Date Received
April 12, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Normalizing Quantitative Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.

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