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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Auditory, Evoked Response
510(k) Number K242954
Device Name Integrity V500 (Integrity, Integrity with VEMP)
Applicant
Vivosonic, Inc.
222-5535 Eglinton Ave. W.
Toronto,  CA M9C 5K5
Applicant Contact Trevor Rocheleau
Correspondent
Vivosonic, Inc.
222-5535 Eglinton Ave. W.
Toronto,  CA M9C 5K5
Correspondent Contact Trevor Rocheleau
Regulation Number882.1900
Classification Product Code
GWJ  
Subsequent Product Code
EWO  
Date Received09/25/2024
Decision Date 12/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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