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

    RMI TRANSILLUMINATOR, MODEL 292

    K Number: K812949 · Decision Dec 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    12
    Review Days
    42

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    Basic Information

    Device Name
    RMI TRANSILLUMINATOR, MODEL 292
    K Number
    K812949
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1945
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Radiation Measurements, Inc.
    Date Received
    October 21, 1981
    Decision Date
    December 2, 1981
    Product Code
    HJM
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HJM Transilluminator, Ac-Powered

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