BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    OXFORD RETRO-ILLUMINATION CATARACT CAMERA

    K Number: K873157 · Decision Sep 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    155
    Applicant Total
    1
    Review Days
    51

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    Basic Information

    Device Name
    OXFORD RETRO-ILLUMINATION CATARACT CAMERA
    K Number
    K873157
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Holofax , Ltd.
    Date Received
    August 10, 1987
    Decision Date
    September 30, 1987
    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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