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

    AVL MODEL 912 CO-OXYLITE

    K Number: K895466 · Decision Nov 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    4
    Applicant Total
    33
    Review Days
    56

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    Basic Information

    Device Name
    AVL MODEL 912 CO-OXYLITE
    K Number
    K895466
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Avl Scientific Corp.
    Date Received
    September 11, 1989
    Decision Date
    November 6, 1989
    Product Code
    GLY
    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
    GLY Oximeter To Measure Hemoglobin

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