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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 BK940032
Tradename Bair Hugger Patient Warming Device
Device Name Device, Warming, Blood and Plasma
Original Applicant
Augustine Medical, Inc.
10393 west 70 th street
eden prairie,  MN  55344
Regulation Number864.9205
Classification Product Code
KZL  
Date Received06/01/1994
Decision Date 09/29/1994
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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