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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 BK180232
Tradename Patient Health Software (P.H.S)
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
MAK-SYSTEM SA International Group
10 avenue de la grande-armee
Paris,  75017, 
Regulation Number864.9165
Classification Product Code
MMH  
Date Received07/20/2018
Decision Date 10/18/2018
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
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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