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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 K221772
Device Name NeuroRPM
Applicant
New Touch Digital, Inc.
3124 Dumbarton St. NW
Washington,  DC  20007
Applicant Contact Chan Lee
Correspondent
New Touch Digital, Inc.
3124 Dumbarton St. NW
Washington,  DC  20007
Correspondent Contact Chan Lee
Regulation Number882.1950
Classification Product Code
GYD  
Subsequent Product Code
ISD  
Date Received06/21/2022
Decision Date 03/17/2023
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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