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

    VISTECH VCTS GLARE TESTER

    K Number: K853481 · Decision Oct 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    107
    Same Product Code
    31
    Applicant Total
    7
    Review Days
    70

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    Basic Information

    Device Name
    VISTECH VCTS GLARE TESTER
    K Number
    K853481
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Vistech Consultants, Inc.
    Date Received
    August 20, 1985
    Decision Date
    October 29, 1985
    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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    Other Clearances by Vistech Consultants, Inc.

    K Number Device Name
    K882634 VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE
    K881059 MCT 8000 (MULTI-VISION CONTRAST TESTER)
    K881023 VCTS 6500 SYSTEM
    K881021 VCTS 700S SYSTEM
    K881022 VCTS MARKETING PROGRAM SYSTEM
    K840255 VISTECH VCTS 6000