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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(K) Number K113082
Device Name SONOVISION
Applicant
PERIDOT TECHNOLOGIES NY INC
9131 queens blvd.
suite u
elmhurst,  NY  11373
Contact omar barlas
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/18/2011
Decision Date 03/08/2012
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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