BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇹 Italy

    MAIA, MODEL 1

    K Number: K092187 · Decision May 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    59
    Same Product Code
    40
    Applicant Total
    7
    Review Days
    310

    Basic Information

    Device Name
    MAIA, MODEL 1
    K Number
    K092187
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1605
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CENTERVUE SPA
    Date Received
    July 21, 2009
    Decision Date
    May 27, 2010
    Product Code
    HPT
    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
    HPT Perimeter, Automatic, Ac-Powered

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