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

    D.L. SCOPE OPHTHALMOSCOPE

    K Number: K896072 · Decision Nov 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    46
    Applicant Total
    6
    Review Days
    39

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    Basic Information

    Device Name
    D.L. SCOPE OPHTHALMOSCOPE
    K Number
    K896072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    North American Medical Products, Inc.
    Date Received
    October 19, 1989
    Decision Date
    November 27, 1989
    Product Code
    HLJ
    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
    HLJ Ophthalmoscope, Battery-Powered

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