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

    GALAXY SYSTEM; JUPITER

    K Number: K111055 · Decision Dec 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    250

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    Basic Information

    Device Name
    GALAXY SYSTEM; JUPITER
    K Number
    K111055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Personal Health Institute International
    Date Received
    April 15, 2011
    Decision Date
    December 21, 2011
    Product Code
    OLV
    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
    OLV Standard Polysomnograph With Electroencephalograph

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