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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood establishment computer software and accessories
510(k) Number BK170032
Tradename Blood Product Administration Module, Version 2-2017
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Epic Systems Corporation
1979 milky way
verona,  WI  53593
Regulation Number864.9165
Classification Product Code
MMH  
Date Received04/03/2017
Decision Date 06/28/2017
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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