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510(k) K240668

Amydi-med Disposable Non-invasive EEG electrodes by Shenzhen Amydi-Med Electrics Tech Co., Ltd. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2024
Date Received
March 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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