BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ECMO-TEMP (TM) BLOOD WARMING DEVICE

    K Number: K873699 · Decision Dec 22, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    29
    Applicant Total
    12
    Review Days
    97

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    Basic Information

    Device Name
    ECMO-TEMP (TM) BLOOD WARMING DEVICE
    K Number
    K873699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Seabrook Medical Systems, Inc.
    Date Received
    September 16, 1987
    Decision Date
    December 22, 1987
    Product Code
    DWC
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWC Controller, Temperature, Cardiopulmonary Bypass

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    Other Clearances by Seabrook Medical Systems, Inc.

    K Number Device Name
    K946196 TROPICAIR CONVECTIVE WARING SYSTEM
    K952086 TROPICAIR CONVECTIVE WARMING BLANKETS
    K931203 COOL-AID
    K923104 TROPIC-AIR
    K914182 GOLDEN THERMAL(R)
    K902756 TROPI-COOL
    K902269 ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY
    K902268 PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.
    K882310 DUAL-TEMP(TM) COOLING/WARMING UNIT
    K881322 MINI-TEMP(TM)
    Search all 12 clearances from Seabrook Medical Systems, Inc. →