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

    TEAR VOLUME TESTS

    K Number: K881515 · Decision May 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    42

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    Basic Information

    Device Name
    TEAR VOLUME TESTS
    K Number
    K881515
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1800
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Visionex, Inc.
    Date Received
    April 11, 1988
    Decision Date
    May 23, 1988
    Product Code
    KYD
    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
    KYD Strip, Schirmer

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