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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K162460
Device Name WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts
Applicant
Wavi Co.
3535 S. Irving St.
Englewood,  CO  80110
Applicant Contact ALEXIS VERACRUZ
Correspondent
Wavi Co.
3535 S. Irving St.
Englewood,  CO  80110
Correspondent Contact DAVID JONES
Regulation Number882.1320
Classification Product Code
GXY  
Date Received09/02/2016
Decision Date 04/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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