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

    CRYSTAL-EEG MODEL 15

    K Number: K001110 · Decision Jul 5, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    25
    Applicant Total
    8
    Review Days
    90

    Basic Information

    Device Name
    CRYSTAL-EEG MODEL 15
    K Number
    K001110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CLEVELAND MEDICAL DEVICES, INC.
    Date Received
    April 6, 2000
    Decision Date
    July 5, 2000
    Product Code
    OMC
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OMC Reduced- Montage Standard Electroencephalograph

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