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

    HEMOGLOBINOMETER

    K Number: K832288 · Decision Sep 1, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    8
    Applicant Total
    92
    Review Days
    50

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    Basic Information

    Device Name
    HEMOGLOBINOMETER
    K Number
    K832288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6710
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mallinckrodt Critical Care
    Date Received
    July 13, 1983
    Decision Date
    September 1, 1983
    Product Code
    KMG
    Advisory Committee
    General Hospital
    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
    KMG Purifier, Water, Ultraviolet, Medical

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