BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VISUCAM

    K Number: K021787 · Decision Jun 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    12
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    22

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    Basic Information

    Device Name
    VISUCAM
    K Number
    K021787
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    892.2010
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carl Zeiss Ophthalmic Systems, Inc.
    Date Received
    May 30, 2002
    Decision Date
    June 21, 2002
    Product Code
    NFF
    Advisory Committee
    Radiology
    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
    NFF Device, Storage, Images, Ophthalmic

    Other Clearances by Carl Zeiss Ophthalmic Systems, Inc.

    K Number Device Name
    K012727 HUMPHREY OCT3