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

    THE OCUPLOT D

    K Number: K822415 · Decision Sep 7, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    27

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    Basic Information

    Device Name
    THE OCUPLOT D
    K Number
    K822415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1360
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Coherent Medical Division
    Date Received
    August 11, 1982
    Decision Date
    September 7, 1982
    Product Code
    HPJ
    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
    HPJ Instrument, Visual Field, Laser

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