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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 BK251188
Tradename Patient Health Software (P.H.S.)
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
MAK-SYSTEM Group Ltd.
1 bartholomew lane
London,  EC2N 2AX,  UNITED KINGDOM
Regulation Number864.9165
Classification Product Code
MMH  
Date Received03/28/2025
Decision Date 06/11/2025
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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