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

    OPD-STATION SOFTWARE

    K Number: K050336 · Decision Aug 24, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    3
    Applicant Total
    77
    Review Days
    195

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    Basic Information

    Device Name
    OPD-STATION SOFTWARE
    K Number
    K050336
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1760
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nidek, Inc.
    Date Received
    February 10, 2005
    Decision Date
    August 24, 2005
    Product Code
    NCF
    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
    NCF Aberrometer, Ophthalmic

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