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

    THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)

    K Number: K050350 · Decision Apr 29, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    59
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    77

    Basic Information

    Device Name
    THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)
    K Number
    K050350
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1605
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NOTAL VISION, INC.
    Date Received
    February 11, 2005
    Decision Date
    April 29, 2005
    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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