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

    COMPUMEDICS E-SERIES EEG SYSTEM

    K Number: K000068 · Decision Mar 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    53
    Applicant Total
    1
    Review Days
    63

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    Basic Information

    Device Name
    COMPUMEDICS E-SERIES EEG SYSTEM
    K Number
    K000068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Compumedics Neuro Science Pty , Ltd.
    Date Received
    January 10, 2000
    Decision Date
    March 13, 2000
    Product Code
    OLT
    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
    OLT Non-Normalizing Quantitative Electroencephalograph Software

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