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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K232210
Device Name X-trodes System M
Applicant
X-Trodes
7 Sapir St.
Herzeliya,  IL 4685211
Applicant Contact Ziv Peremen
Correspondent
Biologics Consulting Group
100 Daingerfield Rd.
Suite 400
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Codes
DPS   GXY   IKN  
Date Received07/26/2023
Decision Date 02/04/2024
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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