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

    OLYMPIC CFM 6000

    K Number: K031149 · Decision May 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    37
    Review Days
    34

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    Basic Information

    Device Name
    OLYMPIC CFM 6000
    K Number
    K031149
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympic Medical Corp.
    Date Received
    April 10, 2003
    Decision Date
    May 14, 2003
    Product Code
    OMA
    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
    OMA Amplitude-Integrated Electroencephalograph

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