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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system,x-ray,extraoral source,digital
510(k) Number K120318
Device Name VIVI ERGON-X HF
Original Applicant
VIVI S.R.L.
via borgo santa
cristina ,12
imola,  IT 40026
Original Contact guido bonapace
Regulation Number872.1800
Classification Product Code
MUH  
Subsequent Product Code
EHD  
Date Received02/02/2012
Decision Date 03/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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