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

    OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M

    K Number: K828619 · Decision Jan 3, 1983
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    41

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    Basic Information

    Device Name
    OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M
    K Number
    K828619
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Ohmic , Ltd.
    Date Received
    November 23, 1982
    Decision Date
    January 3, 1983
    Advisory Committee
    Unknown
    Review Advisory Committee
    RA
    Third Party
    N