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

    VCTS 700S SYSTEM

    K Number: K881021 · Decision Apr 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    110
    Same Product Code
    31
    Applicant Total
    7
    Review Days
    22

    Basic Information

    Device Name
    VCTS 700S SYSTEM
    K Number
    K881021
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    VISTECH CONSULTANTS, INC.
    Date Received
    March 10, 1988
    Decision Date
    April 1, 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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