BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SEPCOR UNIT COLLECTION MONITOR

    K Number: K820712 · Decision May 7, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    53

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    Basic Information

    Device Name
    SEPCOR UNIT COLLECTION MONITOR
    K Number
    K820712
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.9195
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Separation Science Corp.
    Date Received
    March 15, 1982
    Decision Date
    May 7, 1982
    Product Code
    KSQ
    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
    KSQ Device, Blood Mixing And Blood Weighing

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