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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 BK940051
Tradename Helmer Water Plasma Thawer
Device Name Device, Warming, Blood and Plasma
Original Applicant
Helmer Labs., Inc.
5415 distribution drive
fort wayne,  IN  46825
Regulation Number864.9205
Classification Product Code
KZL  
Date Received09/13/1994
Decision Date 03/03/1995
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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