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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 BK870011
Tradename ECMO-TEMP
Device Name Device, Warming, Blood and Plasma
Original Applicant
Seabrook Medical Systems, Inc.
673 wilmer aveune
cincinnati,  OH  45226
Regulation Number864.9205
Classification Product Code
KZL  
Date Received05/28/1987
Decision Date 09/14/1987
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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