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

    FLO TEM (FLUID WARNER)

    K Number: K800699 · Decision May 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    41

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    Basic Information

    Device Name
    FLO TEM (FLUID WARNER)
    K Number
    K800699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9205
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Chroma Products, Inc.
    Date Received
    March 28, 1980
    Decision Date
    May 8, 1980
    Product Code
    KZL
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZL Device, Warming. Blood And Plasma

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