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

    RADIOMHTER OSM-2 HEMOXIMETER

    K Number: K771263 · Decision Aug 3, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    4
    Applicant Total
    7
    Review Days
    23

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    Basic Information

    Device Name
    RADIOMHTER OSM-2 HEMOXIMETER
    K Number
    K771263
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    The London Co.
    Date Received
    July 11, 1977
    Decision Date
    August 3, 1977
    Product Code
    GHS
    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
    GHS Assay, Carboxyhemoglobin

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