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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electromechanical arm for a transcranial magnetic stimulation system
510(k) Number K182768
Device Name TMS-Cobot TS MV
Axilum Robotics
8 rue Schertz
Strasbourg,  FR 67100
Applicant Contact Romuald Ginhoux
Hogan Lovells US LLP
1735 Market Street, 23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number882.5805
Classification Product Code
Date Received09/28/2018
Decision Date 02/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No