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

    MIND MAP (20 CHANNEL EEG)

    K Number: K860378 · Decision Aug 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    53
    Applicant Total
    1
    Review Days
    190

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    Basic Information

    Device Name
    MIND MAP (20 CHANNEL EEG)
    K Number
    K860378
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Mind Systems Corp.
    Date Received
    February 3, 1986
    Decision Date
    August 12, 1986
    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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