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

    ERG-JET ELECTRODE

    K Number: K830557 · Decision Mar 31, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    36

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    Basic Information

    Device Name
    ERG-JET ELECTRODE
    K Number
    K830557
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1220
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Universo S.A.
    Date Received
    February 23, 1983
    Decision Date
    March 31, 1983
    Product Code
    HLZ
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HLZ Electrode, Corneal

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