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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, blood mixing and blood weighing
510(k) Number BK040005
Tradename Fresenius Compoguard & Donationmaster NT
Device Name Device, Blood Mixing and Weighing
Original Applicant
Fresenius Medical Care North America
95 hayden avenue
lexington,  MA  02420 9192
Regulation Number864.9195
Classification Product Code
KSQ  
Date Received01/29/2004
Decision Date 03/26/2004
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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