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

    AML (ANGLE MAGNIFYING LENS

    K Number: K823719 · Decision Jan 5, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    155
    Applicant Total
    2
    Review Days
    26

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    Basic Information

    Device Name
    AML (ANGLE MAGNIFYING LENS
    K Number
    K823719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Nikon, Inc.
    Date Received
    December 10, 1982
    Decision Date
    January 5, 1983
    Product Code
    HKI
    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
    HKI Camera, Ophthalmic, Ac-Powered

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