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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, optical position/movement recording
510(k) Number K173931
Device Name MindMotion(TM) GO
Applicant
MindMaze SA
Chemin de Roseneck 5
lausanne,  CH ch-1006
Applicant Contact sylvian bourriquet
Correspondent
MindMaze SA
Chemin de Roseneck 5
lausanne,  CH ch-1006
Correspondent Contact sylvian bourriquet
Regulation Number890.5360
Classification Product Code
LXJ  
Date Received12/26/2017
Decision Date 05/17/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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