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

    VISUCAM PRO NM

    K Number: K052268 · Decision Nov 2, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    68
    Same Product Code
    151
    Applicant Total
    21
    Review Days
    75

    Basic Information

    Device Name
    VISUCAM PRO NM
    K Number
    K052268
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CARL ZEISS MEDITEC AG
    Date Received
    August 19, 2005
    Decision Date
    November 2, 2005
    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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