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

    DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM

    K Number: K913929 · Decision Nov 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    155
    Applicant Total
    5
    Review Days
    85

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    Basic Information

    Device Name
    DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
    K Number
    K913929
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ophthalmic Imaging Systems
    Date Received
    September 3, 1991
    Decision Date
    November 27, 1991
    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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