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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
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