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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 K130228
Device Name SUITEHEART
Applicant
NEOSOFT, LLC
n27 w23910a paul rd.
pewaukee,  WI  53186
Contact jackie schwabe
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/04/2013
Decision Date 03/20/2013
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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