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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, warming. blood and plasma
510(k) Number BK050058
Tradename Fluido Blood and Fluid Warmer System
Device Name Device, Warming, Blood and Plasma
Original Applicant
The Surgical Company International
terminalweg 19a
amersfoort,  3821 AJ, 
Regulation Number864.9205
Classification Product Code
KZL  
Date Received09/28/2005
Decision Date 05/05/2006
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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