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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name device, warming. blood and plasma
510(k) Number BK920005
Tradename AM-4
Device Name Device, Warming, Blood and Plasma
Original Applicant
Futuremed
2076 deer park avenue
deer park,  NY  11729
Regulation Number864.9205
Classification Product Code
KZL  
Date Received10/29/1991
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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