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

    ELECTRORETINOGRAPH

    K Number: K760199 · Decision Aug 4, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    10
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    ELECTRORETINOGRAPH
    K Number
    K760199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1220
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Lkc Technologies, Inc.
    Date Received
    July 7, 1976
    Decision Date
    August 4, 1976
    Product Code
    HLZ
    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
    HLZ Electrode, Corneal

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