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510(k) K183529

AE-120A EEG Head Set by Nihon Kohden Corporation — Product Code OMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2019
Date Received
December 19, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reduced- Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes

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