BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    BRM3 BRAIN MONITOR

    K Number: K071449 · Decision Sep 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    3
    Review Days
    113

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    Basic Information

    Device Name
    BRM3 BRAIN MONITOR
    K Number
    K071449
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brainz Instruments , Ltd.
    Date Received
    May 24, 2007
    Decision Date
    September 14, 2007
    Product Code
    OMA
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    Y

    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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    Other Clearances by Brainz Instruments , Ltd.

    K Number Device Name
    K033010 BRM2 BRAIN MONITOR
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