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510(k) K162460

WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts by Wavi Co. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2017
Date Received
September 2, 2016
Clearance Type
Traditional
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

Other clearances by Wavi Co.

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