BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MOIRE FRINGE VISOMETER AFTER LOTMAR

    K Number: K800238 · Decision Mar 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    34

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    Basic Information

    Device Name
    MOIRE FRINGE VISOMETER AFTER LOTMAR
    K Number
    K800238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1780
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Hagg-Streit Service, Inc.
    Date Received
    February 5, 1980
    Decision Date
    March 10, 1980
    Product Code
    HKL
    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
    HKL Retinoscope, Ac-Powered

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    Other Clearances by Hagg-Streit Service, Inc.

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