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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 BK910007
Tradename MMED Vapor Condensation Blood Warmer
Device Name Device, Warming, Blood and Plasma
Original Applicant
MMED
609 19th avenue, s.w.
rochester,  MN  55902
Regulation Number864.9205
Classification Product Code
KZL  
Date Received04/04/1991
Decision Date 03/16/1992
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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