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510(k) K163644

Nihon Kohden QP-160AK EEG Trend Program by Nihon Kohden Corporation — Product Code OMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2017
Date Received
December 23, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplitude-Integrated Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).

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