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

    PSG-1100 SLEEP DIAGNOSTIC SYSTEM

    K Number: K120888 · Decision Nov 9, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    188
    Applicant Total
    9
    Review Days
    231

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    Basic Information

    Device Name
    PSG-1100 SLEEP DIAGNOSTIC SYSTEM
    K Number
    K120888
    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 Corp.
    Date Received
    March 23, 2012
    Decision Date
    November 9, 2012
    Product Code
    GWQ
    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
    GWQ Full-Montage Standard Electroencephalograph

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