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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 K151955
Device Name YuGo System
Applicant
BIOGAMING LTD.
hamgshimim 20
petach tikva,  IL 4934829
Applicant Contact ronit harpaz
Correspondent
DUET MEDICAL CONSULTING LTD.
10th haanafa st.
zur moshe,  IL 4281000
Correspodent Contact vered nitzan
Classification Product Code
LXJ  
Date Received07/15/2015
Decision Date 02/05/2016
Decision substantially equivalent (SESE)
510k Review Panel Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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