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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 BK960074
Tradename HemoMatic Blood Collection Monitor
Device Name Device, Blood Mixing and Weighing
Original Applicant
Thermogenesis
3146 gold camp drive
suite 206
rancho cordova,  CA  95670 6022
Regulation Number864.9195
Classification Product Code
KSQ  
Date Received10/03/1996
Decision Date 04/03/1997
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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