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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 K242326
Device Name Wave Electrode (AE02-60); Wave Electrode (AE02-50)
Applicant
Bionit Labs Srl
Via Cracovia 1
Soleto,  IT 73010
Applicant Contact Aventaggiato Matteo
Correspondent
Bionit Labs Srl
Via Cracovia 1
Soleto,  IT 73010
Correspondent Contact Aventaggiato Matteo
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
IQZ  
Date Received08/06/2024
Decision Date 01/02/2025
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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