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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 K260455
Device Name New Wave System
Applicant
Zeto, Inc.
5565 Centerview Dr. Suite 105
Raleigh,  NC  27606
Applicant Contact Florian Strelzyk
Correspondent
Innolitics, LLC
1101 W. 34th St. #550
Austin,  TX  78705
Correspondent Contact Ameera Roubi
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GXY  
Date Received02/11/2026
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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