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

    DIATHRON(R) DIATHERMY UNIT

    K Number: K894513 · Decision Oct 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    6
    Review Days
    104

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    Basic Information

    Device Name
    DIATHRON(R) DIATHERMY UNIT
    K Number
    K894513
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1945
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Intl. Ophthalmic Industries Corp.
    Date Received
    July 19, 1989
    Decision Date
    October 31, 1989
    Product Code
    HJM
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    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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