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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 BK990019
Tradename HemoFlow Donor Monitor and Mixer
Device Name Device, Blood Mixing and Weighing
Original Applicant
Applied Sciences, Inc.
964-b golden gate terrace
grass valley,  CA  95945
Regulation Number864.9195
Classification Product Code
KSQ  
Date Received07/12/1999
Decision Date 10/05/1999
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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