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

    SEPCOR TEMPERATURE MONITOR

    K Number: K813327 · Decision Dec 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    37

    Basic Information

    Device Name
    SEPCOR TEMPERATURE MONITOR
    K Number
    K813327
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9700
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    SEPARATION SCIENCE CORP.
    Date Received
    November 24, 1981
    Decision Date
    December 31, 1981
    Product Code
    KSE
    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
    KSE Refrigerator, Freezer, Blood Storage

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