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510(k) K200162

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) by Wuhan Greentek Pty , Ltd. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2020
Date Received
January 22, 2020
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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