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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K213900
Device Name WAVi SCAN EEG System and Accessories
Applicant
WAVi Co.
3459 Ringsby Ct. Ste. #305
Denver,  CO  80216
Applicant Contact David Oakley
Correspondent
WAVi Co.
3459 Ringsby Ct. Ste. #305
Denver,  CO  80216
Correspondent Contact David Jones
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received12/14/2021
Decision Date 05/06/2022
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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