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

    PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM

    K Number: K881358 · Decision Jun 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    107
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM
    K Number
    K881358
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Neuroscientific Corp.
    Date Received
    March 31, 1988
    Decision Date
    June 27, 1988
    Product Code
    HOX
    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
    HOX Chart, Visual Acuity

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