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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Tremor
510(k) Number K250153
Device Name Neu Platform
Applicant
Neuhealth Digital , Ltd.
10 Fitzroy Square
London,  GB W1T 5HP
Applicant Contact Giovanni Maggi
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number882.1950
Classification Product Code
GYD  
Date Received01/21/2025
Decision Date 04/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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