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    K Number
    K051736
    Device Name
    FOX PULSE OXIMETER
    Manufacturer
    SHUNSUKE NAKANISHI
    Date Cleared
    2005-12-02

    (157 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHUNSUKE NAKANISHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Finger Pulse Oximeter is a small portable battery powered device that measures %SpO2, pulse rate, and pulse strength on the finger. It may be used as a spot check device in the home, hospital, or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The pulse oximeter will provide reliable measurements on patients ranging from pediatric to adults. This device is not intended for continous patient monitoring. There are no audible or visible patient alarms.
    Device Description
    Fox Oximeter is a portable, lightweight, and battery-operated device that measures %SpO2 pulse rate, and pulse strength on the finger of a patient.
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