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

    NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A

    K Number: K080546 · Decision Aug 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    53
    Applicant Total
    166
    Review Days
    183

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    Basic Information

    Device Name
    NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
    K Number
    K080546
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nihon Kohden America, Inc.
    Date Received
    February 28, 2008
    Decision Date
    August 29, 2008
    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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