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

    BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE

    K Number: K801659 · Decision Sep 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    14
    Review Days
    50

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    Basic Information

    Device Name
    BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE
    K Number
    K801659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Coburn Optical Ind., Inc.
    Date Received
    July 21, 1980
    Decision Date
    September 9, 1980
    Product Code
    HJO
    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
    HJO Biomicroscope, Slit-Lamp, Ac-Powered

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