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510(k) K201910

EZTrack by Neurologic, LLC — Product Code OLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2020
Date Received
July 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization

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